RESPOND(R) Ventilator
510(k) K241135
RESPOND(R) Ventilator is a Class II device made by Corvent Medical, Inc, cleared under FDA 510(k) K241135 on 13 Nov 2024, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241135 | Date13 Nov 2024 | StatusActive |
Official records
- FDA 510(k) database K241135
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CBK
- FDA applicant
- Corvent Medical, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K241135
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| BV Filters | 91-101-US305 / BV Filters | 00850057117189 | On the market | |
| Cart, Accessory Bar | 91-101-US312 / Cart, Accessory Bar | 00850057117257 | On the market | |
| Cart, Display Bracket | 91-101-US310 / Cart, Display Bracket | 00850057117233 | On the market | |
| Cart, Display Mount | 91-101-US309 / Cart, Display Mount | 00850057117226 | On the market | |
| Cart, Humidifier Mount | 91-101-US313 / Cart, Humidifier Mount | 00850057117264 | On the market | |
| Cart, IV Pole | 91-101-US311 / Cart, IV Pole | 00850057117240 | On the market | |
| Cart, IV Pole Mount | 91-101-US316 / Cart, IV Pole Mount | 00850057117295 | On the market | |
| Cart, IV Power Strip | 91-101-US319 / Cart, IV Power Strip | 00850057117462 | On the market | |
| Cart, IV Power Strip Mount | 91-101-US318 / Cart, IV Power Strip Mount | 00850057117479 | On the market | |
| Cart, Nebulizer Mount | 91-101-US314 / Cart, Nebulizer Mount | 00850057117271 | On the market | |
| Circuit Arm | 91-101-US308 / Circuit Arm | 00850057117219 | On the market | |
| Exhalation Valve | 91-101-US307 / Exhalation Valve | 00850057117202 | On the market | |
| Exhalation Valve | 91-101-US502 / Exhalation Valve | 00850057117400 | On the market | |
| Flow Sensor | 91-101-US503 / Flow Sensor | 00850057117387 | On the market | |
| Flow Sensor Cable | 91-101-US208 / Flow Sensor Cable | 00850057117103 | On the market | |
| Flow Sensors | 91-101-US209 / Flow Sensors | 00850057117110 | On the market | |
| Flowmeter Kit, 0-70 L/min | 91-101-US211 / Flowmeter Kit, 0-70 L/min | 00850057117134 | On the market | |
| Green Oxygen Hose, 8ft | 91-101-US212 / Green Oxygen Hose, 8ft | 00850057117448 | On the market | |
| HEPA Filters HEPA Filters (Pk of 50) | 91-101-US505 / HEPA Filters (Pk of 50) | 00850057117431 | On the market | |
| HME Filters | 91-101-US306 / HME Filters | 00850057117196 | On the market | |
| Lint Filters | 91-101-US206 / Lint Filters | 00850057117080 | On the market | |
| Nurse Call Cable, Normally Closed | 91-101-US210 / Nurse Call Cable, Normally Closed | 00850057117127 | On the market | |
| Nurse Call Cable, Normally Open | 91-101-US204 / Nurse Call Cable, Normally Open | 00850057117066 | On the market | |
| Oxygen Tubing with Connector, 7ft | 91-101-US213 / Oxygen Tubing with Connector, 7ft | 00850057117455 | On the market | |
| Patient Circuit Arm Clip | 91-101-US320 / Patient Circuit Arm Clip | 00850057117486 | On the market | |
| Patient Circuit Kit | 91-101-US304 / Patient Circuit Kit | 00850057117172 | On the market | |
| Removeable Batt. Chrg, 4-slot, 30% Max Charge | 91-101-US315 / Removeable Batt. Chrg, 4-slot, 30% Max Charge | 00850057117288 | On the market | |
| Removeable Battery | 91-101-US301 / Removeable Battery | 00850057117141 | On the market | |
| Removeable Battery Charger, 1-slot | 91-101-US302 / Removeable Battery Charger, 1-slot | 00850057117158 | On the market | |
| Removeable Battery Charger, 4-slot | 91-101-US303 / Removeable Battery Charger, 4-slot | 00850057117165 | On the market | |
| RESPOND Exhalation Manifold | 91-101-US202 / RESPOND Exhalation Manifold | 00850057117059 | On the market | |
| RESPOND Exhalation Manifold | 91-101-US501 / RESPOND Exhalation Manifold | 00850057117394 | On the market | |
| RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/ | 91-101-US504 / RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/ | 00850057117417 | On the market | |
| RESPOND Power Supply (US) | 91-101-US201 / RESPOND Power Supply (US) | 00850057117042 | On the market | |
| RESPOND Ventilator | 3461-03-1002 / RESPOND Ventilator | 00850057117004 | On the market | |
| RESPOND Ventilator | 91-101-US100 / RESPOND Ventilator | 00850057117370 | On the market | |
| RESPOND Ventilator Cart | 91-101-US207 / RESPOND Ventilator Cart | 00850057117097 | On the market | |
| RESPOND Ventilator Kit | 91-101-US101 / RESPOND Ventilator Kit | 00850057117011 | On the market | |
| RESPOND Ventilator Kit w/ Rugged Case | 91-101-US201 / RESPOND Ventilator Kit w/ Rugged Case | 00850057117035 | On the market | |
| RESPOND Ventilator Kit w/o Battery | 91-101-US102 / RESPOND Ventilator Kit w/o Battery | 00850057117028 | On the market | |
| Serial EHR Cable | 91-101-US205 / Serial EHR Cable | 00850057117073 | On the market |
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