Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Catheter Research, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
162 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123258 | THE ADVANCE CATHETER FOR HSG AND SIS | Catheter Research, Inc. | 2013-01-31 | 105 | 0 |
| K120154 | INTRAUTERINE INSEMINATION (IUI) CATHETER | Catheter Research, Inc. | 2012-03-21 | 63 | 0 |
| K032835 | H/S CATHETER SET | Catheter Research, Inc. | 2003-12-11 | 91 | 1 |
| K020292 | UTERINE INJECTOR | Catheter Research, Inc. | 2002-04-17 | 79 | 1 |
| K973839 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Catheter Research, Inc. | 1998-03-19 | 162 | 0 |
| K974357 | UTERINE MANIPULATOR/INJECTOR | Catheter Research, Inc. | 1998-02-02 | 75 | 0 |
| K951345 | DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING | Catheter Research, Inc. | 1995-04-14 | 22 | 0 |
| K946044 | DISPOSABLE GAS SAMPLING LINES | Catheter Research, Inc. | 1994-12-27 | 15 | 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