Tri-Med Specialties, Inc.: FDA clearances and approvals
Tri-Med Specialties, Inc. has 14 FDA 510(k) clearances (first 1985, latest 1997), across 8 product codes in 2 review panels. Median 510(k) review time: 189 days.
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 |
|---|---|---|---|
| LRO | General Surgery Tray | 3 | 3 |
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | 2 | 2 |
| KNQ | Dilator, Esophageal | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| OCX | Endoscopic Irrigation/Suction System | 2 | 2 |
| BSS | Tube, Nasogastric | 1 | 1 |
| GBT | Catheter, Rectal | 1 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
Review panels
Most recent Tri-Med Specialties, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971615 | PATTISON ESOPHAGEAL DILATOR | KNQ | 1997-07-24 | 83 |
| K970890 | #ES-32 SUCTION CATHETER 32 FR. | KNT | 1997-05-23 | 73 |
| K970982 | T-RX RETRIEVAL FORCEPS | OCZ | 1997-05-09 | 52 |
| K942918 | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER | OCX | 1995-02-28 | 252 |
| K950574 | NEEDLE/CANNULA | LRO | 1995-02-24 | 28 |
| K934348 | TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR | BSS | 1994-12-23 | 472 |
| K945160 | PARACENTESIS NEEDLES/CANNULAS | LRO | 1994-11-14 | 24 |
| K924549 | TRI-MED QUICK-STEP(TM) RECTAL TUBE | GBT | 1994-02-10 | 519 |
| K932015 | TRI-MED INFLATABLE ESOPHAGEAL DILATOR | KNQ | 1994-02-03 | 286 |
| K932652 | TRI-MED PARACENTESIS TRAY | LRO | 1993-11-24 | 175 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tri-Med Specialties, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Tri-Med Specialties, Inc. have?
Tri-Med Specialties, Inc. has 14 FDA 510(k) clearances (first 1985, latest 1997), across 8 product codes in 2 review panels.
How long does FDA take to clear Tri-Med Specialties, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Tri-Med Specialties, Inc.'s cleared 510(k)s is 189 days.
What devices does Tri-Med Specialties, Inc. make?
Its most frequent FDA product codes are LRO (General Surgery Tray, 3); KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration, 2); KNQ (Dilator, Esophageal, 2).
Has Tri-Med Specialties, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Tri-Med Specialties, Inc. Related entities may recall under other names.
Next steps
- See all 14 Tri-Med Specialties, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRO, Tri-Med Specialties, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.