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

Ulti-Med Intl., Inc. — Predicate Candidate Screening

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

61 daysmedian FDA review time
231 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103011ULTICARE SAFETY INSULIN SYRINGEUlti-Med Intl., Inc.2011-02-021130
K923176SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.1993-06-173700
K923175SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.1993-06-173700
K920989SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.1992-10-192310
K922828ULCER WOUND TRAYUlti-Med Intl., Inc.1992-09-281080
K914244STERILE CUSTOM SURGICAL KITSUlti-Med Intl., Inc.1992-02-241540
K914431ABSORBENT FIBERUlti-Med Intl., Inc.1991-12-04610
K912692CONFORMING BANDAGEUlti-Med Intl., Inc.1991-10-041080
K912693POST OPERATIVE SPONGEUlti-Med Intl., Inc.1991-10-041080
K904896EYE PADUlti-Med Intl., Inc.1990-12-05360
K901465ABSORBABLE GAUZE DRAPEUlti-Med Intl., Inc.1990-06-12770
K891717PATIENT EXAMINATION GLOVES (VINYL)Ulti-Med Intl., Inc.1989-05-11510
K874296INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STERUlti-Med Intl., Inc.1988-01-07790
K874318MAXIMUM CONTROL GOWNUlti-Med Intl., Inc.1987-12-02430
K873439LACERATION TRAYUlti-Med Intl., Inc.1987-09-11150
K873175CENTRAL SUPPLY ROOM WRAPUlti-Med Intl., Inc.1987-09-09280
K865023COVER, SHOE OPERATING ROOMUlti-Med Intl., Inc.1987-01-12200
K865022SURGICAL GARMENTSUlti-Med Intl., Inc.1987-01-12200
K860936ABSORBENT, FIBER, OPERATING ROOM TOWELSUlti-Med Intl., Inc.1986-04-04230
K842572GAUZE & LAB SPONGES STERILE & NONUlti-Med Intl., Inc.1984-08-15430
K832858INTRADISCAL THERAPY TRAYUlti-Med Intl., Inc.1983-09-29370

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