Trinity Laboratories, Inc.: FDA filings under this applicant name
FDA lists 44 510(k) clearances under the applicant name “Trinity Laboratories, Inc.” (first 1990, latest 1998), across 32 product codes in 9 review panels. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | 8 | 8 |
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 2 | 2 |
| KMF | Bandage, Liquid | 2 | 2 |
| LRO | General Surgery Tray | 2 | 2 |
| MCZ | Suture Removal Kit | 2 | 2 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 1 | 1 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
Plus 22 more product codes.
Review panels
- General Hospital (13)
- General and Plastic Surgery (12)
- Anesthesiology (7)
- Microbiology (4)
- Gastroenterology and Urology (2)
- Immunology (2)
- Cardiovascular (1)
- Dental (1)
- Obstetrics and Gynecology (1)
Most recent Trinity Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981441 | HEART CATH TRAY, STERILE, DISPOSABLE | DQO | 1998-07-10 | 80 |
| K974238 | DENTAL TRAY, STERILE, DISPOSABLE | EIA | 1998-02-04 | 84 |
| K974286 | CIRCUMCISION TRAY, CAT. NO. 70340 | HFX | 1997-12-12 | 28 |
| K972160 | CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST | DCK | 1997-08-01 | 53 |
| K970722 | EYE TRAY | KKX | 1997-03-31 | 32 |
| K965201 | O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE | LRO | 1997-02-14 | 50 |
| K964921 | BASIC BIOPSY TRAY. DISPOSABLE, STERILE | LRO | 1997-01-22 | 44 |
| K953929 | MID-STREAM COLLECTION SET-STERILE | LIO | 1995-11-16 | 87 |
| K952058 | STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE | FOZ | 1995-09-21 | 142 |
| K953070 | WOUNDFOAM 4 X 4 | KMF | 1995-09-08 | 70 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Trinity Laboratories, 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.
- Trinity Biotech USA (11 510(k)s)
- Trinity Biotech (7 510(k)s)
- Trinity Biotech, Plc (5 510(k)s)
- Trinity Orthopedics, LLC (2 510(k)s)
- Trinity Biotech (Primus Corporation, Dba Trinity Biotech) (1 510(k)s)
- Trinity Guardion (1 510(k)s)
- Trinity Medical Solutions (1 510(k)s)
- Trinity Partners, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trinity Laboratories, Inc.?
FDA lists 44 510(k) clearances under the applicant name “Trinity Laboratories, Inc.” (first 1990, latest 1998), across 32 product codes in 9 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 Trinity Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trinity Laboratories, Inc. is 91 days.
Which FDA product codes appear under Trinity Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are KKX (Drape, Surgical, Antimicrobial, 8); BSY (Catheters, Suction, Tracheobronchial, 2); BTO (Tube, Tracheostomy (W/Wo Connector), 2).
Next steps
- See all 44 Trinity Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KKX, Trinity Laboratories, 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.