Quali-Med, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Quali-Med, Inc.” (first 1986, latest 1987), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Quali-Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871408 | BLOOD VESSEL CONNECTOR | — | 1987-04-27 | 19 |
| K862972 | DISPOSABLE MIRROR | — | 1986-09-23 | 48 |
| K862472 | QUARTZ RODS TITANIUM RODS | GEX | 1986-09-12 | 74 |
| K862241 | STANDARD BASIN KIT CUSTOM BASIN KIT | FRG | 1986-08-01 | 50 |
| K862242 | PAP SMEAR KIT | HHT | 1986-06-26 | 14 |
| K862172 | QUALI-MED'S OPERATING ROOM DRAPES | KKX | 1986-06-19 | 10 |
| K861198 | CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES) | — | 1986-05-16 | 46 |
Recalls
openFDA lists no recalls under a recalling firm named Quali-Med, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Quali-Med, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Quali-Med, Inc.” (first 1986, latest 1987), across 5 product codes in 3 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 Quali-Med, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quali-Med, Inc. is 46 days.
Which FDA product codes appear under Quali-Med, Inc.?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 1); GEX (Powered Laser Surgical Instrument, 1); HHT (Spatula, Cervical, Cytological, 1).
Next steps
- See all 7 Quali-Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Quali-Med, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.