Welmed Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Welmed Systems, Inc.” (first 1986, latest 1986), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 27 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 |
|---|---|---|---|
| KOD | Catheter, Urological | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| LRQ | Tracheostomy And Nasal Suctioning Kit | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Welmed Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863282 | CARE + PLUS CATHETER CARE TRAY | KOD | 1986-10-31 | 67 |
| K863281 | CARE + PLUS IRREGATION TRAY | KOD | 1986-10-31 | 67 |
| K863497 | SUCTION CATHETER KIT | BSY | 1986-10-06 | 27 |
| K863284 | I.V. START KIT | — | 1986-09-22 | 28 |
| K863283 | CARE + PLUS SUTURE REMOVAL TRAY | — | 1986-09-15 | 21 |
| K862663 | TRACHEOSTOMY CARE TRAY | LRQ | 1986-07-30 | 16 |
| K862219 | T.P.N. DRESSING CHANGE TRAY | — | 1986-07-08 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Welmed Systems, Inc..
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.
- Welmed, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Welmed Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Welmed Systems, Inc.” (first 1986, latest 1986), across 4 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 Welmed Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Welmed Systems, Inc. is 27 days.
Which FDA product codes appear under Welmed Systems, Inc.?
The most frequent FDA product codes under this applicant name are KOD (Catheter, Urological, 2); BSY (Catheters, Suction, Tracheobronchial, 1); LRQ (Tracheostomy And Nasal Suctioning Kit, 1).
Next steps
- See all 7 Welmed Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KOD, Welmed Systems, 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.