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

Kmi Kolster Methods, Inc. — Predicate Candidate Screening

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

154 daysmedian FDA review time

249 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K060414	KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE	Kmi Kolster Methods, Inc.	2006-10-23	249	1
K043591	FEATHERLIFT EXTENDED APTOS THREAD	Kmi Kolster Methods, Inc.	2005-03-04	66	0
K012236	STARS2000 POWER CANNULA	Kmi Kolster Methods, Inc.	2001-11-19	125	0
K010702	XUB EXTERNAL ULTRASOUND	Kmi Kolster Methods, Inc.	2001-08-09	154	0
K002859	SSW-STERILE SOLUTION WARMER	Kmi Kolster Methods, Inc.	2000-11-16	64	0
K991203	IRRIGATION OR INFUSION PUMP K PUMP	Kmi Kolster Methods, Inc.	1999-10-15	190	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