Westmed Intl.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Westmed Intl.” (first 1993, latest 1996), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BXY | Flowmeter, Calibration, Gas | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| BYG | Mask, Oxygen | 1 | 1 |
| CAW | Generator, Oxygen, Portable | 1 | 1 |
| EMX | Balloon, Epistaxis | 1 | 1 |
| LYA | Splint, Intranasal Septal | 1 | 1 |
Review panels
Most recent Westmed Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955047 | WESTMED CIRCULARIE PEP DEVICES | BYE | 1996-03-27 | 145 |
| K954271 | WESTMED CONDESATE COLLECTION TRAP | CAW | 1995-12-28 | 107 |
| K952616 | MICROTIME | BTI | 1995-09-27 | 113 |
| K953687 | WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER | CAH | 1995-09-18 | 42 |
| K953506 | WESTMED RESPIRATORY LUER ADAPTOR | BXY | 1995-09-15 | 51 |
| K951484 | WESTMED BACTERIAL/VIRAL FILTER | CAH | 1995-04-24 | 25 |
| K945472 | WESTMED PEDIATRIC AND ADULT AEROSOL MASK | BYG | 1995-02-07 | 91 |
| K924944 | INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA | EMX | 1993-07-02 | 275 |
| K925173 | BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT | LYA | 1993-01-15 | 93 |
Recalls
openFDA lists no recalls under a recalling firm named Westmed Intl..
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.
- Westmed, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Westmed Intl.?
FDA lists 9 510(k) clearances under the applicant name “Westmed Intl.” (first 1993, latest 1996), across 8 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 Westmed Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Westmed Intl. is 93 days.
Which FDA product codes appear under Westmed Intl.?
The most frequent FDA product codes under this applicant name are CAH (Filter, Bacterial, Breathing-Circuit, 2); BTI (Compressor, Air, Portable, 1); BXY (Flowmeter, Calibration, Gas, 1).
Next steps
- See all 9 Westmed Intl. clearances with predicates and recalls
- Run predicate analysis for product code CAH, Westmed Intl.'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.