Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Innovations, LLC · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
472 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M) | Clinical Innovations, LLC | 2025-10-08 | 250 | 0 |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | Clinical Innovations, LLC | 2025-05-22 | 58 | 0 |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | Clinical Innovations, LLC | 2023-02-24 | 58 | 0 |
| K153591 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2016-01-14 | 29 | 0 |
| K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2015-03-25 | 19 | 1 |
| K140163 | KOALA TOCO | Clinical Innovations, LLC | 2014-05-29 | 127 | 0 |
| K131781 | CLEARVIEW TOTAL | Clinical Innovations, LLC | 2014-05-28 | 345 | 0 |
| K110605 | ROM PLUS | Clinical Innovations, LLC | 2011-11-23 | 266 | 0 |
| K061539 | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISI | Clinical Innovations, LLC | 2007-09-20 | 472 | 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