FDA Product Code
FDA Product Code FLE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.6880
510(k) Clearances — 185 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K020747 | AMSCO CENTURY MEDIUM STERILIZER 26 X 26 | STERIS Corporation | 2002-05-17 | Abbreviated | PDF ↗ |
| K020590 | MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER | Getinge/Castle, Inc. | 2002-03-20 | Special | PDF ↗ |
| K014174 | HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 | Barnstead/Thermolyne Corp. | 2002-02-22 | Traditional | PDF ↗ |
| K012573 | CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC | Getinge/Castle, Inc. | 2001-09-05 | Special | PDF ↗ |
| K010865 | AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY | STERIS Corporation | 2001-05-31 | Abbreviated | PDF ↗ |
| K003470 | EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870 | Tuttnauer Co. , Ltd. | 2001-02-20 | Abbreviated | PDF ↗ |
| K993856 | TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP | Tuttnauer U.S.A Co, Ltd. | 2001-02-09 | Traditional | PDF ↗ |
| K003441 | CASTLE MODEL 233HC STEAM STERILIZER | Getinge/Castle, Inc. | 2001-01-02 | Special | PDF ↗ |
| K000077 | STERIS AMSCO MILLENNIUM STEAM STERILIZER | STERIS Corporation | 2000-03-17 | Special | PDF ↗ |
| K994314 | CASTLE SERIES 100HC STEAM STERILIZERS | Getinge/Castle, Inc. | 2000-02-16 | Special | PDF ↗ |
| K992744 | MIDMARK M4*9 EASYCLAVE STEAM STERILIZER | Midmark Corp. | 2000-01-10 | Traditional | PDF ↗ |
| K991575 | PRIMUS STEAM STERILIZERS | Primus Sterilizer Co., Inc. | 1999-12-03 | Abbreviated | PDF ↗ |
| K990189 | MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Midmark Corp. | 1999-04-19 | Traditional | PDF ↗ |
| K982332 | STERIS TEN SIXTEEN STEAM STERILIZER | STERIS Corporation | 1999-01-20 | Traditional | PDF ↗ |
| K983679 | STATIM 5000 CASSETTE AUTOCLAVE | Scican | 1999-01-04 | Special | PDF ↗ |
| K964332 | EAGLE CENTURY STEAM STERILIZER | Amsco Intl., Inc. | 1998-06-01 | Traditional | PDF ↗ |
| K980014 | THE SYSTEM 2S STEAM STERILIZER | STERIS Corporation | 1998-05-15 | Traditional | PDF ↗ |
| K962903 | PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE | Prestige Medical Corp. | 1998-03-03 | Traditional | PDF ↗ |
| K973225 | CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) | Getinge/Castle, Inc. | 1998-02-10 | Traditional | PDF ↗ |
| K962282 | TUTTNAUER PREVACUUM TABLE AUTOCLAVE | Tuttnauer U.S.A Co, Ltd. | 1997-11-12 | Traditional | PDF ↗ |
| K970907 | CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) | Getinge/Castle, Inc. | 1997-11-12 | Traditional | PDF ↗ |
| K973550 | TUTTNAUER TABLE-TOP AUTOCLAVE | Tuttnauer U.S.A Co, Ltd. | 1997-10-29 | Traditional | PDF ↗ |
| K954142 | STERRADD STERILIZATION SYSTEM | Advanced Sterilization Products | 1997-06-06 | Traditional | PDF ↗ |
| K962755 | STRYKER ENCORE STERILIZER | Stryker Corp. | 1997-03-04 | Traditional | PDF ↗ |
| K945117 | DELTA | Pelton & Crane Co. | 1997-02-28 | Traditional | PDF ↗ |
| K953938 | STERILEMAX | Barnstead/Thermolyne Corp. | 1997-01-30 | Traditional | PDF ↗ |
| K962179 | STAT IM 5000 CASSETTE AUTOCLAVE | Scican | 1997-01-13 | Traditional | PDF ↗ |
| K944036 | STERIMASTER AUTOCLAVE | Scican | 1996-10-02 | Traditional | PDF ↗ |
| K954736 | ACCESS (POWERCLAVE) | Mdt Biologic Co. | 1996-08-15 | Traditional | PDF ↗ |
| K961230 | EASTERCLAVE | Easter Services, Inc. | 1996-06-27 | Traditional | PDF ↗ |
| K951557 | EASTERCLAVE | Easter Services, Inc. | 1995-09-29 | Traditional | PDF ↗ |
| K951273 | BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER | Buxton Medical Servic Corp. | 1995-08-08 | Traditional | PDF ↗ |
| K942989 | OCR II & OCM II | Chambermaid Products Co. | 1995-07-07 | Traditional | PDF ↗ |
| K950341 | BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER | Barnard and Assoc. | 1995-04-19 | Traditional | PDF ↗ |
| K936181 | MIDMARK M-11 ULTRACLAVE STEAM STERILIZER | Midmark Corp. | 1994-11-30 | Traditional | PDF ↗ |
| K926185 | PRIMUS PSS SERIES STERILIZERS | Primus Sterilizer Co., Inc. | 1994-05-09 | Traditional | PDF ↗ |
| K924596 | SES-2012 AUTOMATIC STEAM STERILIZER | Porter Instrument Co., Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K924955 | MDT/HARVEY MC-8 AND MC-10 | Mdt Corp., Inc. | 1993-10-15 | Traditional | PDF ↗ |
| K920478 | TUTTNAUER LSI (AUTOMATIC) | Tuttnauer Co. , Ltd. | 1993-07-08 | Traditional | PDF ↗ |
| K921613 | STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510 | Dept. of the Army | 1993-01-29 | Traditional | PDF ↗ |
| K915054 | STATIM CASSETT AUTOCLAVE, MODIFICATION | Scican | 1992-08-04 | Traditional | PDF ↗ |
| K912471 | EAGLE 3000 SDS | Amsco Co. | 1992-06-26 | Traditional | PDF ↗ |
| K920293 | DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY | Davis & Geck, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K910777 | MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER | Mdt Biologic Co. | 1992-03-27 | Traditional | PDF ↗ |
| K911206 | MAXIMA-10 | Stirn Industries | 1991-11-29 | Traditional | PDF ↗ |
| K910778 | STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) | Mdt Biologic Co. | 1991-10-28 | Traditional | PDF ↗ |
| K910789 | KAVOKLAVE STEAM AUTOCLAVE | Kavo America | 1991-08-26 | Traditional | PDF ↗ |
| K911322 | MODEL #M9 ULTRACLAVE STEAM STERILIZER | Midmark Corp. | 1991-08-26 | Traditional | PDF ↗ |
| K910241 | STATIM CASSETTE AUTOCLAVE | Scican | 1991-05-03 | Traditional | PDF ↗ |
| K903614 | HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE | Harvard Apparatus, Inc. | 1990-12-14 | Traditional | PDF ↗ |
| K901147 | JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT | Joslyn Valve Corp. | 1990-11-30 | Traditional | PDF ↗ |
| K895275 | MAC LAVE STEAM STERILIZER | Merchants Export Development Corp. | 1990-11-23 | Traditional | PDF ↗ |
| K903613 | HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) | Harvard Apparatus, Inc. | 1990-11-07 | Traditional | PDF ↗ |
| K903096 | RACK-IT (R) | Vengo Industries, Inc. | 1990-10-01 | Traditional | PDF ↗ |
| K900432 | MODEL #M8 ELECTRONIC STERILIZER | Midmark Corp. | 1990-07-27 | Traditional | PDF ↗ |
| K895638 | STEAM STERILIZER (AUTOCLAVE), DENTAL | Porter Instrument Co., Inc. | 1990-02-22 | Traditional | PDF ↗ |
| K895848 | PRESSURE STEAM STERILIZERS | Scientific Device Laboratory, Inc. | 1989-12-11 | Traditional | PDF ↗ |
| K893886 | MITEK STERILIZATION TRAY | Mitek Surgical Products, Inc. | 1989-08-21 | Traditional | PDF ↗ |
| K890359 | RESUBMITTED STC SERIES 8600 AUTOCLAVE | Sterilizer Technologies Corp. | 1989-08-07 | Traditional | PDF ↗ |
| K885140 | MULTI-PURPOSE CONTROL SYSTEM | Colliers Sterilizer Sales & Service Co., Inc. | 1989-03-29 | Traditional | PDF ↗ |
| K882713 | REBUILDING STERILIZERS | Mdt Corp., Inc. | 1988-08-12 | Traditional | PDF ↗ |
| K882465 | MODEL 172-P AND 172-N ROTARY SPRAY ARM | Boling Precision Components Co. | 1988-06-24 | Traditional | PDF ↗ |
| K874644 | STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON | Pharmetics, Inc. | 1988-01-27 | Traditional | PDF ↗ |
| K870975 | MODIFIED CASTLE POWERCLAVE | Castle Co. | 1987-04-17 | Traditional | PDF ↗ |
| K862495 | STARCRAFT ELITE AUTOCLAVE | Starcraft Medical Corp. | 1986-10-22 | Traditional | PDF ↗ |
| K852113 | ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 | Ars Enterprises, Inc. | 1985-09-27 | Traditional | PDF ↗ |
| K852114 | ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 | Ars Enterprises, Inc. | 1985-09-27 | Traditional | PDF ↗ |
| K844649 | ELECTRICALLY HEATED STERILIZER STEAM STERILIZER | Takizawa Medical Instruments Manufacturer | 1985-08-05 | Traditional | PDF ↗ |
| K850264 | TUTTNAUER PRE-VACUUM AUTOCLAVE | Tuttnauer Co. , Ltd. | 1985-06-04 | Traditional | PDF ↗ |
| K842631 | STERELIS SEALING EQUIPMENT | Sterelis Corp. | 1984-07-26 | Traditional | PDF ↗ |
| K831356 | STEAM STERILIZER | Ars Enterprises, Inc. | 1984-07-18 | Traditional | PDF ↗ |
| K834152 | ETHYLENE OXIDE DETECTOR GLD-1-07 | Calnor of EL Paseo, Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K833837 | AMERICAN GOLD SERIES AUTOCLAVE | Tuttnauer Co. , Ltd. | 1984-01-11 | Traditional | PDF ↗ |
| K830931 | PORTABLE AUTOCLAVES | Arnold & Sons | 1983-07-27 | Traditional | PDF ↗ |
| K823457 | NON-PRESSURE AUTOCLAVE FOR STERILIZATION | Interdent, Inc. | 1983-02-23 | Traditional | PDF ↗ |
| K821591 | STEAM STERILIZATION EQUIPMENT | Getinge International, Inc. | 1982-06-22 | Traditional | PDF ↗ |
| K801309 | RITTER STERILIZER | Sybron Corp. | 1980-06-20 | Traditional | PDF ↗ |
| K800080 | STERILIZING CASE CAT. NO. 65199 | Edward Weck, Inc. | 1980-01-28 | Traditional | PDF ↗ |
| K792558 | CONTAINER SYSTEM | Aesculap Instruments Corp. | 1979-12-27 | Traditional | PDF ↗ |
| K781684 | STERILIZER, EAGLE 2000 | American Sterilizer Co. | 1978-10-24 | Traditional | PDF ↗ |
| K771229 | STERILIZERS, 3100 SERIES TRIM LINE | Castle Co. | 1977-08-02 | Traditional | PDF ↗ |
| K770682 | STERILIZER, SERIES 3000, MODIFICATION TO | Castle Co. | 1977-05-20 | Traditional | PDF ↗ |
| K770536 | STEAM STERILIZER, 3000 | Castle Co. | 1977-04-29 | Traditional | PDF ↗ |
| K770372 | STERILIZER, STEAM, CASTLE 3000 | Castle Co. | 1977-04-05 | Traditional | PDF ↗ |
| K761032 | CRADLING SYSTEM | Medin Corp. | 1977-01-26 | Traditional | PDF ↗ |
Product code FLE · Class II · General Hospital. Data: openFDA.