Thomas Medical Products, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Thomas Medical Products, Inc.” (first 1990, latest 2013), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 127 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 | 1 | 209 |
| 2013 | 1 | 172 |
| 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 17 | 17 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| DRC | Trocar | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
Review panels
- Cardiovascular (23)
Most recent Thomas Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122431 | HEARTSPAN STEERABLE INTRODUCER KIT | DYB | 2013-01-29 | 172 |
| K120158 | CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS | DYB | 2012-08-14 | 209 |
| K101015 | GUIDE CATHETERS AND ACCESSORIES | DQY | 2010-09-23 | 164 |
| K083269 | CROSSOVER | DYB | 2009-02-03 | 90 |
| K081341 | REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) | DYB | 2008-05-14 | 1 |
| K072745 | Y-GLIDE | DTL | 2008-01-04 | 99 |
| K043438 | LARGE BORE SPLITTABLE INTRODUCER KIT | DYB | 2005-02-15 | 63 |
| K040713 | MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM | DYB | 2004-06-01 | 75 |
| K011727 | TRANSSEPTAL NEEDLE/TROCAR | DRC | 2002-05-02 | 332 |
| K020090 | MODIFICATION TO TRANSSEPTAL INTRODUCER SET | DYB | 2002-02-11 | 32 |
13 earlier clearances. See the full list in Caduvo.
Recalls
17 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2011-10-07.
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.
- Thomas Industries (9 510(k)s)
- Thomas J. Fogarty, M.D. (6 510(k)s)
- Thomas Medical, Inc. (2 510(k)s)
- Thomas G. Mason (1 510(k)s)
- Thomas M. Foti, M.D. (1 510(k)s)
- Thomas Surgical Instruments, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Thomas Medical Products, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Thomas Medical Products, Inc.” (first 1990, latest 2013), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Thomas Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thomas Medical Products, Inc. is 127 days.
Which FDA product codes appear under Thomas Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 17); DQY (Catheter, Percutaneous, 3); DRC (Trocar, 1).
Next steps
- See all 23 Thomas Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Thomas Medical Products, 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.