FDA Product Code
FDA Product Code MNT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5895
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-06 | Traditional | PDF ↗ |
| K242931 | HFT750U | Mekics Co., Ltd. | 2025-05-15 | Traditional | PDF ↗ |
| K240779 | Vivo 3 | Breas Medical AB | 2024-12-13 | Traditional | PDF ↗ |
| K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 | Traditional | PDF ↗ |
| K230173 | Servo-air Lite Ventilator System | Maquet Critical Care AB | 2023-07-06 | Traditional | PDF ↗ |
| K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022-07-01 | Traditional | PDF ↗ |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | Fisher & Paykel Healthcare Limited | 2020-03-09 | Traditional | PDF ↗ |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small | Fisher and Paykel Healthcare Limited | 2017-08-24 | Traditional | PDF ↗ |
| K122715 | STELLAR 150 | Resmed Germany, Inc. | 2013-06-17 | Traditional | PDF ↗ |
| K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2012-12-14 | Abbreviated | PDF ↗ |
| K113640 | STELLAR 150 | Resmed Germany, Inc. | 2012-04-05 | Traditional | PDF ↗ |
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | Respironics, Inc. | 2011-04-05 | Traditional | PDF ↗ |
| K103167 | STELLAR 150 | Resmed Germany, Inc. | 2011-03-01 | Traditional | PDF ↗ |
| K090113 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2009-05-14 | Traditional | PDF ↗ |
| K082660 | V60 VENTILATOR, MODEL V8000 | Respironics California, Inc. | 2009-01-09 | Traditional | PDF ↗ |
| K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | Breas Medical AB | 2008-02-15 | Traditional | PDF ↗ |
| K060044 | ACUTE CARE FACE MASK, MODEL RT040 | Fisher & Paykel Healthcare, Ltd. | 2006-04-06 | Traditional | PDF ↗ |
| K053607 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2006-03-16 | Traditional | PDF ↗ |
| K003075 | KNIGHTSTAR 330 VENTILATOR | Mallinckrodt, Inc. | 2001-12-11 | Traditional | PDF ↗ |
| K990574 | STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 | Respironics, Inc. | 1999-05-24 | Traditional | PDF ↗ |
| K982454 | BIPAP VISION VENTILATORY SUPPORT | Respironics, Inc. | 1998-11-03 | Traditional | PDF ↗ |
| K974539 | SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM | Resmed, Ltd. | 1998-08-06 | Traditional | PDF ↗ |
| K973004 | KNIGHTSTAR 335 | Puritan Bennett Corp. | 1998-07-16 | Traditional | PDF ↗ |
| K955324 | BIPAP S/T-D 30 SYSTEM | Respironics, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K951264 | BIPAP MODEL S/T-D | Respironics, Inc. | 1996-07-29 | Traditional | PDF ↗ |
Product code MNT · Class II · Anesthesiology. Data: openFDA.