Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Innovations, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
169 daysmedian FDA review time
201 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | Clinical Innovations, Inc. | 2003-09-17 | 196 | 1 |
| K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPAS | Clinical Innovations, Inc. | 2003-01-07 | 201 | 0 |
| K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | Clinical Innovations, Inc. | 2001-05-03 | 177 | 0 |
| K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MU | Clinical Innovations, Inc. | 1998-09-22 | 169 | 1 |
| K974563 | COLPO CUP CVC-2000 | Clinical Innovations, Inc. | 1998-03-02 | 87 | 0 |
| K974389 | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUT | Clinical Innovations, Inc. | 1998-02-19 | 90 | 0 |
| K973746 | PRE-FILLED SYRINGE FOR KOALA IUP | Clinical Innovations, Inc. | 1997-11-24 | 54 | 0 |
| K954955 | STORC INTRAUTERINE PRESSURE CATHETER | Clinical Innovations, Inc. | 1996-04-17 | 173 | 0 |
| K940681 | CLEARVIEW UTERINE MANIPULATOR | Clinical Innovations, Inc. | 1994-07-26 | 166 | 2 |
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