Cosmed Srl: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Cosmed Srl” (first 1997, latest 2020), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 280 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 328 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 285 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 315 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Cosmed Srl took a median 300 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 241 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | 3 | 3 |
| BZC | Calculator, Pulmonary Function Data | 3 | 3 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| BZL | Computer, Oxygen-Uptake | 1 | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
Review panels
- Anesthesiology (9)
- Cardiovascular (1)
Most recent Cosmed Srl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | BTY | 2020-02-06 | 315 |
| K162515 | COSMED K5 Wearable Metabolic Technology | BZC | 2017-06-20 | 285 |
| K120146 | QUARK SERIES | CBK | 2012-12-11 | 328 |
| K093174 | SPIROPALM | BZG | 2010-02-26 | 141 |
| K071533 | FITMATE SERIES | BZL | 2007-09-28 | 115 |
| K040549 | COSMED PONY FX | BTY | 2004-09-28 | 210 |
| K020745 | COSMED MICROQUARK | BTY | 2003-01-02 | 301 |
| K014262 | COSMED QUARK C12/QUARK T12 | DPS | 2002-03-26 | 89 |
| K001174 | COSMED QUARK | BZC | 2001-01-11 | 275 |
| K963373 | COSMED K4 | BZC | 1997-09-10 | 379 |
Recalls
openFDA lists no recalls under a recalling firm named Cosmed Srl.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cosmed Nordic Aps (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cosmed Srl?
FDA lists 10 510(k) clearances under the applicant name “Cosmed Srl” (first 1997, latest 2020), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cosmed Srl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cosmed Srl is 280 days.
Which FDA product codes appear under Cosmed Srl?
The most frequent FDA product codes under this applicant name are BTY (Calculator, Predicted Values, Pulmonary Function, 3); BZC (Calculator, Pulmonary Function Data, 3); BZG (Spirometer, Diagnostic, 1).
Next steps
- See all 10 Cosmed Srl clearances with predicates and recalls
- Run predicate analysis for product code BTY, Cosmed Srl's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.