| SV70 Ventilator (SV70) (K252182) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-06 |
| HFT750U (K242931) | Mekics Co., Ltd. | 2025-05-15 |
| Vivo 3 (K240779) | Breas Medical AB | 2024-12-13 |
| F&P Airvo 3 NIV (PT311US) (K233643) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| Servo-air Lite Ventilator System (K230173) | Maquet Critical Care AB | 2023-07-06 |
| Nihon Kohden NKV-330 Ventilator System (K213521) | Nihon Kohden Orangemed, Inc. | 2022-07-01 |
| F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version (K191624) | Fisher & Paykel Healthcare Limited | 2020-03-09 |
| 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 (K170367) | Fisher and Paykel Healthcare Limited | 2017-08-24 |
| STELLAR 150 (K122715) | Resmed Germany, Inc. | 2013-06-17 |
| BIPAP A 40 VENTILATORY SUPPORT SYSTEM (K121623) | Respironics, Inc. | 2012-12-14 |
| STELLAR 150 (K113640) | Resmed Germany, Inc. | 2012-04-05 |
| V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS (K102985) | Respironics, Inc. | 2011-04-05 |
| STELLAR 150 (K103167) | Resmed Germany, Inc. | 2011-03-01 |
| BREAS VIVO 40 SYSTEM (K090113) | Breas Medical AB | 2009-05-14 |
| V60 VENTILATOR, MODEL V8000 (K082660) | Respironics California, Inc. | 2009-01-09 |
| BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 (K071702) | Breas Medical AB | 2008-02-15 |
| ACUTE CARE FACE MASK, MODEL RT040 (K060044) | Fisher & Paykel Healthcare, Ltd. | 2006-04-06 |
| BREAS VIVO 40 SYSTEM (K053607) | Breas Medical AB | 2006-03-16 |
| KNIGHTSTAR 330 VENTILATOR (K003075) | Mallinckrodt, Inc. | 2001-12-11 |
| STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 (K990574) | Respironics, Inc. | 1999-05-24 |
| BIPAP VISION VENTILATORY SUPPORT (K982454) | Respironics, Inc. | 1998-11-03 |
| SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM (K974539) | Resmed, Ltd. | 1998-08-06 |
| KNIGHTSTAR 335 (K973004) | Puritan Bennett Corp. | 1998-07-16 |
| BIPAP S/T-D 30 SYSTEM (K955324) | Respironics, Inc. | 1996-12-20 |
| BIPAP MODEL S/T-D (K951264) | Respironics, Inc. | 1996-07-29 |