Medway: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medway” (first 1991, latest 1994), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 186 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 |
|---|---|---|---|
| KMI | Monitor, Bed Patient | 2 | 2 |
| BYG | Mask, Oxygen | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
Review panels
- General Hospital (4)
- Anesthesiology (1)
Most recent Medway 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934344 | HOME AMB-ALERT | KMI | 1994-04-29 | 233 |
| K931952 | MEDWAY OXYGEN MASK | BYG | 1993-08-20 | 122 |
| K911251 | FLEX-IV | FOZ | 1991-10-28 | 221 |
| K911079 | AMB-ALERT | KMI | 1991-09-13 | 186 |
| K910880 | COMFOR-BOARD | KMK | 1991-06-06 | 97 |
Recalls
openFDA lists no recalls under a recalling firm named Medway.
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 Medway?
FDA lists 5 510(k) clearances under the applicant name “Medway” (first 1991, latest 1994), 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 Medway?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medway is 186 days.
Which FDA product codes appear under Medway?
The most frequent FDA product codes under this applicant name are KMI (Monitor, Bed Patient, 2); BYG (Mask, Oxygen, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Next steps
- See all 5 Medway clearances with predicates and recalls
- Run predicate analysis for product code KMI, Medway'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.