Product code MOD
- Device name
- Accessory To Continuous Ventilator (Respirator)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5895
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260051 | CorVision® (91-205-Z0014) | CorVent® Medical, Inc. | 2026-05-12 |
| K242485 | EveryWare | Breas Medical AB | 2025-05-20 |
| K161411 | Care Cycle Connect Application | Respironics, Inc. | 2017-02-17 |
| K091461 | BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE | Cardiopulmonary Corp. | 2009-08-14 |
| K052751 | VENTLINK SYSTEM | Mediserve Information Systems, Inc. | 2005-12-23 |
| K052244 | IISIS, VERSION 1.0 | Innovision Medical Technologies, LLC | 2005-10-13 |
| K040712 | AIR SAFETY HEPA, MODEL 3500 | Air Safety, Ltd. | 2004-06-03 |
| K022062 | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 | Impact Instrumentation, Inc. | 2003-05-06 |
| K010401 | TRI-PLEX ADAPTER | The Medical Device Group, Inc. | 2002-10-30 |
| K011861 | BERNOULLI VENTILATOR MANAGEMENT SYSTEM | Cardiopulmonary Corp. | 2001-11-06 |
| K963633 | VENTNET; CENTRAL MONITORING STATION | Puritan Bennett Corp. | 1996-12-16 |
| K935788 | BICORE SMARTCATH INTRATRACHEAL CATHETER | Bicore Monitoring Systems | 1995-07-03 |
| K936156 | VENTILATION MECHANICS MONITOR MODEL VMM-100 | Smith Industries Medical Systems (Sims) | 1995-06-27 |
| K940739 | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR | Newport Medical Instruments, Inc. | 1995-03-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850057117509 | CorVision with Display | CORVENT MEDICAL, INC | 2026-05-26 |
| 00850057117493 | Cart, Display Enclosure 11 inch | CORVENT MEDICAL, INC | 2026-05-26 |
| 00850057117516 | CorVent® CorVision | CORVENT MEDICAL, INC | 2026-05-19 |
| 00813841022304 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2023-06-12 |
| 10840330700198 | Procure | Twin Med, LLC | 2022-11-02 |
| 30840330700192 | Procure | Twin Med, LLC | 2022-11-02 |
| 00813841021277 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00813841021642 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00813841021635 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00813841021628 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00813841021611 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00813841021581 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00813841021574 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00813841021567 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00813841021307 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00813841021260 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2019-10-04 |
| 00709078002243 | HEPA Filter | WESTMED, INC. | 2016-12-30 |
| 00709078001017 | Filter | WESTMED, INC. | 2016-12-23 |
| 00709078000980 | Filter | WESTMED, INC. | 2016-12-23 |
| 00709078001000 | Filter | WESTMED, INC. | 2016-12-23 |
| 15060120952537 | Respironics Domed (Gherkin) | GVS FILTER TECHNOLOGY UK LTD | 2016-09-23 |
| 35060120952555 | Inogen | GVS FILTER TECHNOLOGY UK LTD | 2016-09-23 |
| 25060120952541 | Tyco-Achieva Bulk | GVS FILTER TECHNOLOGY UK LTD | 2016-09-23 |
| 25060120952534 | Respironics Domed (Gherkin) | GVS FILTER TECHNOLOGY UK LTD | 2016-09-23 |
| 15060120952551 | Inogen | GVS FILTER TECHNOLOGY UK LTD | 2016-09-23 |
| 15060120952544 | Tyco-Achieva Bulk | GVS FILTER TECHNOLOGY UK LTD | 2016-09-23 |
| 00813841020010 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2015-11-02 |
| 00813841020034 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2015-11-02 |
| 00813841020041 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2015-11-02 |
| 00813841020058 | Bio-Med Devices, Inc. | BIO-MED DEVICES, INC. | 2015-11-02 |