Keymed (Medical & Industrial Equipment), Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Keymed (Medical & Industrial Equipment), Ltd.” (first 1988, latest 2010), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 164 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 |
|---|---|---|---|
| FEQ | Pump, Air, Non-Manual, For Endoscope | 2 | 2 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | 2 | 2 |
| FZK | Chair, Surgical, Non-Electrical | 1 | 1 |
| KNQ | Dilator, Esophageal | 1 | 1 |
Review panels
Most recent Keymed (Medical & Industrial Equipment), Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100899 | OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 | FEQ | 2010-09-13 | 166 |
| K011725 | OLYMPUS SUCTION PUMP, MODEL KV-5 | JCX | 2001-08-31 | 88 |
| K000948 | OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1 | FEQ | 2000-05-12 | 50 |
| K962528 | OLYMPUS MOBILE CHAIR/COUCH | FZK | 1996-12-12 | 168 |
| K930852 | OLYMPUS SUCTION PUMP MODEL KV-4 | JCX | 1994-03-31 | 406 |
| K881478 | MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS | KNQ | 1988-09-14 | 161 |
Recalls
openFDA lists no recalls under a recalling firm named Keymed (Medical & Industrial Equipment), Ltd..
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, Inc. (29 510(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 (Medical & Industrial Equipment), Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Keymed (Medical & Industrial Equipment), Ltd.” (first 1988, latest 2010), across 4 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 Keymed (Medical & Industrial Equipment), Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Keymed (Medical & Industrial Equipment), Ltd. is 164 days.
Which FDA product codes appear under Keymed (Medical & Industrial Equipment), Ltd.?
The most frequent FDA product codes under this applicant name are FEQ (Pump, Air, Non-Manual, For Endoscope, 2); JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered, 2); FZK (Chair, Surgical, Non-Electrical, 1).
Next steps
- See all 6 Keymed (Medical & Industrial Equipment), Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FEQ, Keymed (Medical & Industrial Equipment), Ltd.'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.