Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Kipp Group — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
82 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000343 | NAC Y-ADP | The Kipp Group | 2000-03-01 | 27 | 0 |
| K000152 | KIPPMED I.V. MANIFOLD | The Kipp Group | 2000-02-29 | 41 | 0 |
| K993147 | DECAP | The Kipp Group | 1999-11-02 | 42 | 0 |
| K992268 | NAC PRN NEEDLELESS ACCESS CONNECTOR | The Kipp Group | 1999-09-15 | 71 | 0 |
| K991932 | INTRAVASCULAR ADMINISTRATION SET | The Kipp Group | 1999-08-20 | 73 | 2 |
| K970255 | KIPP MED I.V. MANIFOLD | The Kipp Group | 1997-04-14 | 82 | 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