Z-Medica Corporation: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Z-Medica Corporation” (first 2005, latest 2022), plus 1 De Novo decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 42 days. Since 2017 the median was 186 days, against 214 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Teleflex, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 266 |
| 2014 | 1 | 113 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 186 |
| 2019 | 0 | — |
| 2020 | 1 | 91 |
| 2021 | 0 | — |
| 2022 | 1 | 254 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Z-Medica Corporation took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 214 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | 10 | 10 |
| POD | Temporary, Internal Use Hemostatic | 3 | 2 |
| LYA | Splint, Intranasal Septal | 1 | 1 |
Review panels
Most recent Z-Medica Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220971 | QuikClot Control+ Hemostatic Dressing | POD | 2022-12-14 | 254 |
| K200167 | QuikClot Control+ | POD | 2020-04-23 | 91 |
| K181641 | QuikClot Radial | QSY | 2018-12-24 | 186 |
| K140757 | D2 HEMOSTANTIC DRESSING | QSY | 2014-07-17 | 113 |
| K123387 | QUIKCLOT HEMOSTATIC DRESSING | QSY | 2013-04-12 | 161 |
| K120782 | INTERVENTIONAL HEMOSTATIC BANDAGE | QSY | 2013-03-20 | 370 |
| K090620 | QUIKCLOT INTEVENTIONAL, MODEL P/N 182 | QSY | 2009-04-08 | 30 |
| K080247 | QUIKCLOT NOSEBLEED | LYA | 2008-02-27 | 27 |
| K072474 | QUIKCLOT EX | QSY | 2007-10-16 | 42 |
| K070010 | QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER | QSY | 2007-01-25 | 22 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160012 | De Novo | Temporary, Internal Use Hemostatic | 2017-06-30 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2021-09-22.
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.
Device clinical trials
An industry sponsor named Z-Medica Corporation is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04415606: QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding (Completed, started 2020-06-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Z-Medica Corporation?
FDA lists 13 510(k) clearances under the applicant name “Z-Medica Corporation” (first 2005, latest 2022), plus 1 De Novo decision, across 3 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 Z-Medica Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Z-Medica Corporation is 42 days. Since 2017: 186 days, versus 214 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Z-Medica Corporation?
The most frequent FDA product codes under this applicant name are QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics, 10); POD (Temporary, Internal Use Hemostatic, 3); LYA (Splint, Intranasal Septal, 1).
Next steps
- See all 13 Z-Medica Corporation clearances with predicates and recalls
- Run predicate analysis for product code QSY, Z-Medica Corporation'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.