Microtek Medical, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Microtek Medical, Inc.” (first 1984, latest 2025), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 87 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 | 1 | 109 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Microtek Medical, Inc. took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 3 | 3 |
| KAE | Forceps, Ent | 3 | 3 |
| FYA | Gown, Surgical | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| DWJ | System, Thermal Regulating | 1 | 1 |
| DZI | Drill, Bone, Powered | 1 | 1 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| EPP | Splint, Nasal | 1 | 1 |
| ETB | Prosthesis, Partial Ossicular Replacement | 1 | 1 |
| FWP | Prosthesis, Chin, Internal | 1 | 1 |
Plus 9 more product codes.
Review panels
- Ear, Nose and Throat (11)
- General Hospital (5)
- Cardiovascular (4)
- General and Plastic Surgery (3)
- Dental (1)
- Radiology (1)
Most recent Microtek Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | LHI | 2025-09-16 | 109 |
| K110358 | VENODYNE V810 | JOW | 2011-05-05 | 87 |
| K102971 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK | FYA | 2011-02-23 | 140 |
| K062899 | MICROTEK MEDICAL SURGICAL GOWN/TOGA | FYA | 2007-01-25 | 120 |
| K060200 | MICROTEK MEDICAL WARMING DRAPE | KKX | 2006-05-31 | 125 |
| K050322 | MICROTEK EQUIPMENT DRAPES | KKX | 2005-05-17 | 97 |
| K022903 | CHILLBUSTER | DWJ | 2002-11-27 | 85 |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | MUI | 2002-05-16 | 52 |
| K011318 | VENODYNE DVT ADVANTAGE PLUS | JOW | 2001-10-25 | 177 |
| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | JOW | 2001-01-09 | 209 |
15 earlier clearances. See the full list in Caduvo.
Recalls
25 product recalls in 8 recall events; 9 initiated in the last five years. Most recent: 2025-04-13.
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.
- Microtek International, Inc. (1 510(k)s)
- Microtek Medical, Inc. an Ecolab Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microtek Medical, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Microtek Medical, Inc.” (first 1984, latest 2025), across 19 product codes in 6 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 Microtek Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microtek Medical, Inc. is 87 days.
Which FDA product codes appear under Microtek Medical, Inc.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 3); KAE (Forceps, Ent, 3); FYA (Gown, Surgical, 2).
Next steps
- See all 25 Microtek Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Microtek Medical, 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.