Zargis Medical Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zargis Medical Corp.” (first 2004, latest 2009), across 1 product code in 1 review panel. Median 510(k) review time under this name: 95 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 | 0 | — |
| 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 |
|---|---|---|---|
| DQD | Stethoscope, Electronic | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Zargis Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090493 | SIGNAL | DQD | 2009-08-07 | 163 |
| K083309 | ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33 | DQD | 2009-02-13 | 95 |
| K060197 | ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 | DQD | 2006-03-29 | 62 |
| K042128 | MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) | DQD | 2004-09-08 | 33 |
| K031517 | ZARGIS ACOUSTIC CARDIOSCAN | DQD | 2004-05-26 | 377 |
Recalls
openFDA lists no recalls under a recalling firm named Zargis Medical Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Zargis Medical Corp.?
FDA lists 5 510(k) clearances under the applicant name “Zargis Medical Corp.” (first 2004, latest 2009), 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 Zargis Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zargis Medical Corp. is 95 days.
Which FDA product codes appear under Zargis Medical Corp.?
The most frequent FDA product codes under this applicant name are DQD (Stethoscope, Electronic, 5).
Next steps
- See all 5 Zargis Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQD, Zargis Medical Corp.'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.