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

Unimar, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time

327 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K932432	KRONNER REINFORCING STYLETTE	Unimar, Inc.	1994-04-12	327	0
K920803	HSG TRAY	Unimar, Inc.	1992-10-19	241	3
K910317	UNI-SEM(TM)	Unimar, Inc.	1991-05-01	97	0
K904473	KRONNER MANIPUJECTOR	Unimar, Inc.	1990-12-14	74	0
K895659	HUI MINI-FLEX	Unimar, Inc.	1989-12-19	90	0
K895403	ASPIRETTE ENDOCERVICAL ASPIRATOR	Unimar, Inc.	1989-11-29	83	0
K894264	KDF-2.3	Unimar, Inc.	1989-08-15	56	0
K890848	CERVEX-BRUSH	Unimar, Inc.	1989-05-11	79	0
K854415	ENDOMETRIAL PIPELLE	Unimar, Inc.	1986-03-13	129	0
K810291	STERILE/DISPOSABLE HSG TRAY	Unimar, Inc.	1981-03-18	43	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