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

Apple Medical Corp. · Predicate Candidate Screening

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

82 daysmedian FDA review time

217 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061651	FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154,	Apple Medical Corp.	2006-10-20	129	1
K050256	APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR	Apple Medical Corp.	2005-04-26	82	0
K041131	APPLE MEDICAL OB MOBIUS ELASTIC RETRACTOR	Apple Medical Corp.	2004-05-13	13	0
K014005	APPLE MEDICAL MOBIUS ELASTIC RETRACTOR	Apple Medical Corp.	2002-02-15	72	0
K000026	APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER	Apple Medical Corp.	2000-03-31	86	0
K970788	PNEUMO-MATIC INSUFFLATION NEEDLE	Apple Medical Corp.	1997-03-27	23	0
K961460	LWEET CONE BIOPSY INSTRUMENT	Apple Medical Corp.	1996-11-19	217	8
K952841	THE ASSISTANT	Apple Medical Corp.	1995-08-18	58	0
K941506	URETERAL ILLUMINATOR	Apple Medical Corp.	1994-10-05	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