Tri-State Hospital Supply Corp.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Tri-State Hospital Supply Corp.” (first 1981, latest 2008), across 14 product codes in 5 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 | 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 |
|---|---|---|---|
| HFX | Clamp, Circumcision | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FMQ | Restraint, Protective | 1 | 1 |
| FOS | Catheter, Umbilical Artery | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
| HIC | Speculum, Vaginal, Nonmetal, Fiberoptic | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
Plus 4 more product codes.
Review panels
- General Hospital (6)
- General and Plastic Surgery (4)
- Obstetrics and Gynecology (3)
- Gastroenterology and Urology (2)
- Anesthesiology (1)
Most recent Tri-State Hospital Supply Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080448 | CENTURION PROTECTIVE RESTRAINT, SCR SERIES | FMQ | 2008-08-28 | 191 |
| K080524 | CENTURION SORBAVIEW OTC | NAD | 2008-04-23 | 57 |
| K942353 | CENTURION UMBILICAL CATHETER | FOS | 1995-08-15 | 455 |
| K945977 | CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSING | MGP | 1995-03-29 | 111 |
| K931748 | CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS | LJT | 1994-02-25 | 323 |
| K935491 | CENTURION MOGEN CLAMP/CIRCUMCISION (STER/NON STER) | HFX | 1994-02-17 | 94 |
| K923812 | CENTURION DISPOSABLE INSTRUMENTS | MDM | 1992-12-17 | 141 |
| K910906 | CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS | FPK | 1991-04-01 | 27 |
| K897100 | CENTURION VAGINAL SPECULUM | HIC | 1990-03-16 | 85 |
| K896320 | CENTURION KLEEN-NEEDLE SYSTEM | FMI | 1990-01-11 | 71 |
6 earlier clearances. See the full list in Caduvo.
Recalls
27 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2009-01-14.
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.
- Tri-State (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tri-State Hospital Supply Corp.?
FDA lists 16 510(k) clearances under the applicant name “Tri-State Hospital Supply Corp.” (first 1981, latest 2008), across 14 product codes in 5 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 Tri-State Hospital Supply Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tri-State Hospital Supply Corp. is 85 days.
Which FDA product codes appear under Tri-State Hospital Supply Corp.?
The most frequent FDA product codes under this applicant name are HFX (Clamp, Circumcision, 2); KNT (Tubes, Gastrointestinal (And Accessories), 2); BSY (Catheters, Suction, Tracheobronchial, 1).
Next steps
- See all 16 Tri-State Hospital Supply Corp. clearances with predicates and recalls
- Run predicate analysis for product code HFX, Tri-State Hospital Supply Corp.'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.