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

Iop, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time

145 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K090078	KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT	Iop, Inc.	2009-05-08	116
K062252	MOLTENO3	Iop, Inc.	2006-09-27	55
K053622	SURGISIS OCULAR GRAFT	Iop, Inc.	2006-03-15	77
K010852	OSMED TISSUE EXPANDER	Iop, Inc.	2001-08-13	145
K003646	SUTUREGROOVE WEIGHT SIZING SET	Iop, Inc.	2001-02-22	87
K994289	SUTUREGROOVE	Iop, Inc.	2000-04-17	118
K972143	MOA BONE / M-SPHERE	Iop, Inc.	1997-10-16	132
K902489	MODIFIED MOLTENO(TM) IMPLANTS	Iop, Inc.	1990-08-14	90
K890598	MOLTENO IMPLANT	Iop, Inc.	1989-02-27	21

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