Keymed, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Keymed, Inc.” (first 1981, latest 2010), across 19 product codes in 6 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | 4 | 4 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 3 | 3 |
| FPO | Stretcher, Wheeled | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 2 |
| KNQ | Dilator, Esophageal | 2 | 2 |
| NZA | Accessories, Germicide, Cleaning, For Endoscopes | 2 | 2 |
| DRM | Compressor, Cardiac, External | 1 | 1 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 | 1 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
Plus 9 more product codes.
Review panels
- General Hospital (12)
- Gastroenterology and Urology (11)
- General and Plastic Surgery (2)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
- Radiology (1)
Most recent Keymed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100803 | OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 | FEQ | 2010-04-22 | 31 |
| K921179 | OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20 | FEB | 1993-03-29 | 385 |
| K881004 | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR | FCX | 1988-05-12 | 64 |
| K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR | NVE | 1987-02-12 | 276 |
| K864801 | THE KEYMED HI-LIGHT 250 LIGHT SOURCE | GCT | 1986-12-24 | 15 |
| K862000 | KEYMED FLEXIBLE ESOPHAGEAL DILATORS | KNQ | 1986-08-12 | 81 |
| K860528 | THE KEYMED FIBERSCOPE STERILIZATION CASE | KCT | 1986-07-15 | 154 |
| K861147 | UCS-2, ULTRASONIC CLEANING SOLUTION | FLG | 1986-06-23 | 89 |
| K860704 | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND | NZA | 1986-06-17 | 111 |
| K851149 | KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1 | JAF | 1985-11-26 | 250 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Keymed, 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.
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.
- Keymed (Medical & Industrial Equipment), Ltd. (6 510(k)s)
- Keymed House (2 510(k)s)
- Keymed (Medical and Industrial Equipment) , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Keymed, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Keymed, Inc.” (first 1981, latest 2010), 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 Keymed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Keymed, Inc. is 42 days.
Which FDA product codes appear under Keymed, Inc.?
The most frequent FDA product codes under this applicant name are FEB (Accessories, Cleaning, For Endoscope, 4); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 3); FPO (Stretcher, Wheeled, 3).
Next steps
- See all 29 Keymed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FEB, Keymed, 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.