Cosmed Pony FX
by COSMED Srl
510(k) K040549
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040549 | Date28 Sep 2004 | StatusActive |
Official records
- FDA 510(k) database K040549
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BTY
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1890
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Cosmed Pony FX is a desktop spirometer used for pulmonary function tests. It is an electrical medical device designed to measure and calculate predicted values for pulmonary function assessment.
The device is supplied as a measuring instrument and is intended for use in clinical settings. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device has FDA 510(k) clearance with product code BTY and is classified under regulation number 868.1890.
Devices cleared under K040549
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 | |||
|---|---|---|---|---|
| COSMED Pony FX | Pony FX | 18052400180041 | — | On the market |
| COSMED Pony FX Flowsafe | Pony FX Flowsafe | 18052400180058 | — | On the market |
| COSMED Pony FX MIP/MEP | Pony FX MIP/MEP | 18052400180379 | — | On the market |
Similar devices
Other devices filed under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function).
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- Model 9100 PFT/DICO by Vitalograph Ireland, Ltd.
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- Informed Remote Field Unit Model IFM1000 by Burditt & Calkins-Siemens-Elema
- PFM Professional 7000 Spirometer by Advanced Medical Systems, Inc.
- Sentrysuite Product Line by Carefusion Germany 234 GmbH
- Custo Vit Pulmonary Function Analysis System by Versacor, Inc.
- VIP Pulmonary Function System by Viasys Healthcare GmbH
- CPETWise Platform by Medibyt, Ltd.
- SPIROLOOP-PULMONARY EXERCISE SYSTEM by Pneumedics, Inc.