Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Klein-Baker Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
82 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972731 | NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET | Klein-Baker Medical, Inc. | 1997-09-29 | 69 | 0 |
| K970997 | NEO-CARE LUMBER PUNCTURE KIT | Klein-Baker Medical, Inc. | 1997-05-22 | 64 | 0 |
| K970434 | NEO-PICC | Klein-Baker Medical, Inc. | 1997-04-01 | 55 | 1 |
| K963972 | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | Klein-Baker Medical, Inc. | 1996-12-24 | 82 | 0 |
| K963867 | NEO-CARE CATHETERIZATION TRAY | Klein-Baker Medical, Inc. | 1996-11-06 | 41 | 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