Southwest Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Southwest Technologies, Inc.” (first 1987, latest 2010), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 3 | 3 |
| IPM | Cover, Limb | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
Review panels
Most recent Southwest Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102478 | OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING | FRO | 2010-11-03 | 65 |
| K083334 | ELASTO-GEL MANUKA HONEY WOUND DRESSING | FRO | 2009-07-30 | 260 |
| K030774 | STIMULEN COLLAGEN | KGN | 2004-08-09 | 517 |
| K872488 | ELASTO-GEL CAST & SPLINT PADS | IPM | 1987-09-21 | 90 |
| K872165 | ELASTO-GEL OCCLUSIVE DRESSING | FRO | 1987-06-26 | 21 |
Recalls
6 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2021-05-28.
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.
- Southwest Artificial Eyes, Inc. (2 510(k)s)
- Southwest Medical Mfg., Inc. (2 510(k)s)
- Southwest Ergonomics (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Southwest Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Southwest Technologies, Inc.” (first 1987, latest 2010), across 3 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 Southwest Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Southwest Technologies, Inc. is 90 days.
Which FDA product codes appear under Southwest Technologies, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 3); IPM (Cover, Limb, 1); KGN (Wound Dressing With Animal-Derived Material(S), 1).
Next steps
- See all 5 Southwest Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Southwest Technologies, 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.