Product code MNT
- Device name
- Sv70 Ventilator
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5895
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-06 |
| K242931 | HFT750U | Mekics Co., Ltd. | 2025-05-15 |
| K240779 | Vivo 3 | Breas Medical AB | 2024-12-13 |
| K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| K230173 | Servo-air Lite Ventilator System | Maquet Critical Care AB | 2023-07-06 |
| K213521 | Nihon Kohden NKV-330 Ventilator System | Nihon Kohden Orangemed, Inc. | 2022-07-01 |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | Fisher & Paykel Healthcare Limited | 2020-03-09 |
| 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... | Fisher and Paykel Healthcare Limited | 2017-08-24 |
| K122715 | STELLAR 150 | Resmed Germany, Inc. | 2013-06-17 |
| K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2012-12-14 |
| K113640 | STELLAR 150 | Resmed Germany, Inc. | 2012-04-05 |
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | Respironics, Inc. | 2011-04-05 |
| K103167 | STELLAR 150 | Resmed Germany, Inc. | 2011-03-01 |
| K090113 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2009-05-14 |
| K082660 | V60 VENTILATOR, MODEL V8000 | Respironics California, Inc. | 2009-01-09 |
| K071702 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 | Breas Medical AB | 2008-02-15 |
| K060044 | ACUTE CARE FACE MASK, MODEL RT040 | Fisher & Paykel Healthcare, Ltd. | 2006-04-06 |
| K053607 | BREAS VIVO 40 SYSTEM | Breas Medical AB | 2006-03-16 |
| K003075 | KNIGHTSTAR 330 VENTILATOR | Mallinckrodt, Inc. | 2001-12-11 |
| K990574 | STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 | Respironics, Inc. | 1999-05-24 |
| K982454 | BIPAP VISION VENTILATORY SUPPORT | Respironics, Inc. | 1998-11-03 |
| K974539 | SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM | Resmed, Ltd. | 1998-08-06 |
| K973004 | KNIGHTSTAR 335 | Puritan Bennett Corp. | 1998-07-16 |
| K955324 | BIPAP S/T-D 30 SYSTEM | Respironics, Inc. | 1996-12-20 |
| K951264 | BIPAP MODEL S/T-D | Respironics, Inc. | 1996-07-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09420012480866 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2025-08-13 |
| 09420012465511 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2025-08-13 |
| 08401934313396 | ResScan | RESMED CORP. | 2023-02-24 |
| 08401934313389 | ResScan | RESMED CORP. | 2023-02-24 |
| 09420012460752 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012460790 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012460776 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012460738 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012460639 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012460615 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012460295 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012455727 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012455338 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012455062 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012455000 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 09420012459695 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 00606959038127 | OmniLab Advanced Plus | Respironics, Inc. | 2017-11-28 |
| 09420012436139 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2017-10-13 |
| 09420012436115 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2017-10-13 |
| 09420012436092 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2017-10-13 |
| 09420012436078 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2017-10-13 |
| 00606959033276 | Battery | Respironics, Inc. | 2016-09-23 |
| 00606959008854 | INVASIVE CIRCUIT | Respironics, Inc. | 2016-09-16 |
| 00606959026346 | Circuits | Respironics, Inc. | 2016-09-16 |
| 00606959032019 | A Series | Respironics, Inc. | 2016-08-31 |
| 00606959032064 | A Series Heated Humidifier | Respironics, Inc. | 2016-08-31 |
| 00606959021556 | A Series | Respironics, Inc. | 2016-08-31 |
| 00606959039629 | A Series | Respironics, Inc. | 2016-08-31 |
| 00606959039636 | A Series | Respironics, Inc. | 2016-08-31 |
| 00606959028630 | DirectView | Respironics, Inc. | 2016-02-16 |