Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Kronner Medical — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

53 daysmedian FDA review time

399 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K894228	KRONNER SPHERICAL CUTTERS	Kronner Medical	1990-07-23	399	0
K895171	BLOOD GAS SAFETY SYRINGE	Kronner Medical	1989-11-07	89	0
K895172	KRONNER SACRAL PIN GUIDE	Kronner Medical	1989-09-12	33	0
K895173	SKELETAL FIXATION PIN	Kronner Medical	1989-09-12	33	0
K871248	KRONNER COLLES-FOREARM EXTERNAL FIXATION	Kronner Medical	1987-06-03	65	0
K871249	KRONNER BI-PLANER TIBIA EXTERNAL FIXATION	Kronner Medical	1987-05-22	53	0
K871247	KRONNER UNIVERSAL FRAME EXTERNAL FIXATION	Kronner Medical	1987-05-22	53	25

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