Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Creative Care Systems, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
79 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861406 | NON-KOR WINGED INFUSION SETS | Creative Care Systems, Inc. | 1986-05-06 | 21 | 0 |
| K852831 | NON-KOR ACCESS KITS | Creative Care Systems, Inc. | 1985-09-19 | 79 | 0 |
| K850888 | PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV | Creative Care Systems, Inc. | 1985-05-07 | 64 | 0 |
| K850887 | DRESSING CHANGE KIT | Creative Care Systems, Inc. | 1985-05-01 | 58 | 0 |
| K841742 | NON-CORING NEEDLE | Creative Care Systems, Inc. | 1984-07-06 | 70 | 0 |
| K840919 | DAYPAK SYS VII CATHETER CARE KIT | Creative Care Systems, Inc. | 1984-04-17 | 47 | 0 |
| K840681 | DAYPAK SYSTEM III CATHETER CARE KIT | Creative Care Systems, Inc. | 1984-04-16 | 61 | 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