Westmed, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Westmed, Inc.” (first 1995, latest 2016), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 85 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 | 1 | 212 |
| 2013 | 0 | — |
| 2014 | 1 | 238 |
| 2015 | 1 | 281 |
| 2016 | 1 | 114 |
| 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 3 | 3 |
| BYG | Mask, Oxygen | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 | 1 |
| SDT | Intra-Pulmonary Percussive Vibration (Ipv) Devices | 1 | 1 |
Review panels
- Anesthesiology (6)
- General Hospital (2)
Most recent Westmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162343 | Westmed Gas Sampling Cannula with O2 delivery | CCK | 2016-12-14 | 114 |
| K143148 | Disposable Pressure Manometer (DPM) | CAP | 2015-08-11 | 281 |
| K133057 | VIBRALUNG ACOUSTICAL PERCUSSOR | SDT | 2014-05-23 | 238 |
| K121382 | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] | CAH | 2012-12-06 | 212 |
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | MEB | 2008-07-15 | 12 |
| K072220 | PEDI CO2 EASY | CCK | 2007-08-23 | 13 |
| K070128 | CO2 EASY | CCK | 2007-02-15 | 30 |
| K953464 | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK | BYG | 1995-09-18 | 56 |
Recalls
26 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2024-09-27.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Westmed, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
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 Intl. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Westmed, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Westmed, Inc.” (first 1995, latest 2016), across 6 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 Westmed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Westmed, Inc. is 85 days.
Which FDA product codes appear under Westmed, Inc.?
The most frequent FDA product codes under this applicant name are CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, 3); BYG (Mask, Oxygen, 1); CAH (Filter, Bacterial, Breathing-Circuit, 1).
Next steps
- See all 8 Westmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CCK, Westmed, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.