Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thomas Medical Products, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
209 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122431 | HEARTSPAN STEERABLE INTRODUCER KIT | Thomas Medical Products, Inc. | 2013-01-29 | 172 | 0 |
| K120158 | CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS | Thomas Medical Products, Inc. | 2012-08-14 | 209 | 2 |
| K101015 | GUIDE CATHETERS AND ACCESSORIES | Thomas Medical Products, Inc. | 2010-09-23 | 164 | 0 |
| K083269 | CROSSOVER | Thomas Medical Products, Inc. | 2009-02-03 | 90 | 2 |
| K081341 | REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) | Thomas Medical Products, Inc. | 2008-05-14 | 1 | 0 |
| K072745 | Y-GLIDE | Thomas Medical Products, Inc. | 2008-01-04 | 99 | 2 |
| K043438 | LARGE BORE SPLITTABLE INTRODUCER KIT | Thomas Medical Products, Inc. | 2005-02-15 | 63 | 1 |
| K040713 | MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM | Thomas Medical Products, Inc. | 2004-06-01 | 75 | 1 |
| K011727 | TRANSSEPTAL NEEDLE/TROCAR | Thomas Medical Products, Inc. | 2002-05-02 | 332 | 0 |
| K020090 | MODIFICATION TO TRANSSEPTAL INTRODUCER SET | Thomas Medical Products, Inc. | 2002-02-11 | 32 | 0 |
| K013202 | MODIFICATION TO BRAIDED GUIDING INTRODUCER | Thomas Medical Products, Inc. | 2001-10-23 | 28 | 0 |
| K004025 | SPLITTABLE SHEATH INTRODUCER KIT | Thomas Medical Products, Inc. | 2001-07-19 | 204 | 0 |
| K004026 | BRAIDED GUIDING INTRODUCER | Thomas Medical Products, Inc. | 2001-07-09 | 194 | 0 |
| K003731 | SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASI | Thomas Medical Products, Inc. | 2001-04-10 | 127 | 6 |
| K961780 | HEMODIALYSIS INTRODUCER SET | Thomas Medical Products, Inc. | 1996-12-24 | 230 | 0 |
| K961466 | PERCUTANEOUS INTRODUCER SET | Thomas Medical Products, Inc. | 1996-09-12 | 148 | 0 |
| K934901 | TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VAL | Thomas Medical Products, Inc. | 1994-01-21 | 99 | 7 |
| K931587 | MULTI-PORT Y INTRODUCER SET | Thomas Medical Products, Inc. | 1993-10-06 | 189 | 0 |
| K932619 | TRANSSEPTAL INTRODUCER SET | Thomas Medical Products, Inc. | 1993-08-24 | 84 | 0 |
| K924456 | LONG LENGTH PERCUTANEOUS INTRODUCER SET | Thomas Medical Products, Inc. | 1993-03-22 | 201 | 0 |
| K911130 | HEMOSTATIC Y CONNECTOR | Thomas Medical Products, Inc. | 1991-06-06 | 84 | 0 |
| K904608 | PERCUTANEOUS INTRODUCER TRAY | Thomas Medical Products, Inc. | 1990-12-03 | 53 | 0 |
| K902275 | PERCUTANEOUS INTRODUCER SET | Thomas Medical Products, Inc. | 1990-09-26 | 128 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda