Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
FDA 510(k) clearance K181524 · decided 2018-11-30
Clearance details
- K-number
- K181524
- Device name
- Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
- Applicant
- Vyaire Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-06-11
- Decision date
- 2018-11-30
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- BZC
- Device class
- 2
- Regulation number
- 868.1880
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Hoechber, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Vyaire Medical
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STS (K240293) | Techbopulm, Ltd. | 2024-09-17 |
| Vyntus/SentrySuite Product Line (K183567) | Vyaire Medical | 2019-08-23 |
| Vyntus BODY (K190853) | Vyaire Medical, Inc. | 2019-08-16 |
| COSMED K5 Wearable Metabolic Technology (K162515) | Cosmed Srl | 2017-06-20 |
| MiniBox + (K161295) | Pulmone Advanced Medical Devices, Ltd. | 2016-10-21 |
| Vyntus / SentrySuite Product Line (K150810) | Carefusion Germany 234 GmbH | 2015-08-14 |
| VYNTUS/ SENTRYSUITE PRODUCT LINE (K133925) | Carefusion Germany 234 GmbH | 2014-08-22 |
| PULMONE MINIBOX PFT TM (K133051) | Pulmone Advanced Medical Devices, Ltd. | 2014-05-02 |
| LCI OPTION FOR INNOCOR (K102047) | Innovision A/S | 2011-11-01 |
| MASTERSCREEN & OXYCON CPX (K072323) | Viasys Healthcare GmbH | 2007-10-10 |
| ZAN LUNG-FUNCTION LAB (K052328) | Zan Messgerate GmbH | 2005-12-22 |
| MASTERSCREEN CPX AND OXYCON CPX (K040698) | Viasys Healthcare GmbH | 2004-04-07 |
Recalls involving this device
No recalls on record reference this clearance.