Versamed Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Versamed Medical Systems, Inc.” (first 2004, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 98 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 | 268 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 8 | 8 |
Review panels
- Anesthesiology (8)
Most recent Versamed Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112754 | IVENT101 | CBK | 2012-06-15 | 268 |
| K092135 | MODIFICATION TO IVENT 101 | CBK | 2009-11-23 | 131 |
| K081845 | IVENT101 | CBK | 2009-03-16 | 259 |
| K073694 | IVENT 2001 MRI CONDITIONAL | CBK | 2008-05-30 | 151 |
| K061627 | MODIFICATION TO I VENT 201 | CBK | 2006-06-29 | 17 |
| K053270 | IVENT 201 | CBK | 2006-01-27 | 65 |
| K052554 | MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR | CBK | 2005-09-23 | 7 |
| K042468 | IVENT 201 PORTABLE VENTILATOR | CBK | 2004-11-17 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Versamed Medical Systems, Inc..
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.
- Versamed , Ltd. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Versamed Medical Systems, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Versamed Medical Systems, Inc.” (first 2004, latest 2012), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Versamed Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Versamed Medical Systems, Inc. is 98 days.
Which FDA product codes appear under Versamed Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 8).
Next steps
- See all 8 Versamed Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Versamed Medical Systems, Inc.'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.