Quick-Med Technologies, Inc.: FDA clearances and approvals
Quick-Med Technologies, Inc. has 1 FDA 510(k) clearance (first 2013, latest 2013), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time: 329 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 329 |
| 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 |
|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | 1 | 1 |
| NYS | Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac) | 1 | 0 |
Review panels
Most recent Quick-Med Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121898 | STAY FRESH SKIN FOLD MANAGEMENT TEXTILE | FRL | 2013-05-24 | 329 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN070002 | De Novo | Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac) | 2009-02-25 |
Recalls
openFDA lists no recalls under a recalling firm named Quick-Med Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Quick-Med Technologies, Inc. have?
Quick-Med Technologies, Inc. has 1 FDA 510(k) clearance (first 2013, latest 2013), plus 1 De Novo decision, across 2 product codes in 2 review panels.
How long does FDA take to clear Quick-Med Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Quick-Med Technologies, Inc.'s cleared 510(k)s is 329 days.
What devices does Quick-Med Technologies, Inc. make?
Its most frequent FDA product codes are FRL (Fiber, Medical, Absorbent, 1); NYS (Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac), 1).
Has Quick-Med Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Quick-Med Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 1 Quick-Med Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRL, Quick-Med Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.