Panels › Anesthesiology › Product code MNT · Class 2
Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Regulation 868.5895
1510(k)s in 12 months (25 all time)
0recalls in 12 months (64 all time)
54recalls that name a 510(k)
Top companies in MNT
| Company | 510(k)s | Recalls |
|---|---|---|
| Respironics California, Inc. | 1 | 52 |
| Philips Respironics, Inc. | 0 | 7 |
| Respironics, Inc. | 6 | 1 |
| Breas Medical AB | 4 | 0 |
| Fisher & Paykel Healthcare Limited | 3 | 0 |
| Resmed Germany, Inc. | 3 | 0 |
| Puritan Bennett Corp. | 1 | 1 |
| Resmed, Ltd. | 1 | 1 |
| Bio-Med Devices, Inc. | 0 | 1 |
| DRE Medical Group Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 6, 2026 | K252182 | SV70 Ventilator (SV70) Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MNT |
| May 15, 2025 | K242931 | HFT750U Mekics Co., Ltd., KR | MNT |
| Dec 13, 2024 | K240779 | Vivo 3 Breas Medical AB, SE | MNT |
| Aug 9, 2024 | K233643 | F&P Airvo 3 NIV (PT311US) Fisher & Paykel Healthcare, Ltd., NZ | MNT |
| Jul 6, 2023 | K230173 | Servo-air Lite Ventilator System Maquet Critical Care AB, SE | MNT |
| Jul 1, 2022 | K213521 | Nihon Kohden NKV-330 Ventilator System Nihon Kohden Orangemed, Inc. | MNT |
| Mar 9, 2020 | K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version Fisher & Paykel Healthcare Limited, NZ | MNT |
| Aug 24, 2017 | K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Fisher and Paykel Healthcare Limited, NZ | MNT |
| Jun 17, 2013 | K122715 | STELLAR 150 Resmed Germany, Inc. | MNT |
| Dec 14, 2012 | K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM Respironics, Inc. | MNT |
| Apr 5, 2012 | K113640 | STELLAR 150 Resmed Germany, Inc. | MNT |
| Apr 5, 2011 | K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS Respironics, Inc. | MNT |
| Mar 1, 2011 | K103167 | STELLAR 150 Resmed Germany, Inc., DE | MNT |
| May 14, 2009 | K090113 | BREAS VIVO 40 SYSTEM Breas Medical AB, SE | MNT |
| Jan 9, 2009 | K082660 | V60 VENTILATOR, MODEL V8000 Respironics California, Inc. | MNT |
| Feb 15, 2008 | K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 Breas Medical AB, SE | MNT |
| Apr 6, 2006 | K060044 | ACUTE CARE FACE MASK, MODEL RT040 Fisher & Paykel Healthcare, Ltd., NZ | MNT |
| Mar 16, 2006 | K053607 | BREAS VIVO 40 SYSTEM Breas Medical AB, SE | MNT |
| Dec 11, 2001 | K003075 | KNIGHTSTAR 330 VENTILATOR Mallinckrodt, Inc. | MNT |
| May 24, 1999 | K990574 | STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 Respironics, Inc. | MNT |
| Nov 3, 1998 | K982454 | BIPAP VISION VENTILATORY SUPPORT Respironics, Inc. | MNT |
| Aug 6, 1998 | K974539 | SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM Resmed, Ltd. | MNT |
| Jul 16, 1998 | K973004 | KNIGHTSTAR 335 Puritan Bennett Corp. | MNT |
| Dec 20, 1996 | K955324 | BIPAP S/T-D 30 SYSTEM Respironics, Inc. | MNT |
| Jul 29, 1996 | K951264 | BIPAP MODEL S/T-D Respironics, Inc. | MNT |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.