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

HQN — Predicate Candidate Screening

7 FDA 510(k) clearances under this product code; the 50 most recent screened below.

126 daysmedian FDA review time

232 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K972034	MEDPOR OCULAR CONFORMER	Porex Surgical, Inc.	1998-01-20	232	1
K970319	OCULAR CONFORMER	Xavier A. Guerra, Ocularist, Inc.	1997-07-07	160	0
K970318	OCULAR CONFORMER	Southwest Artificial Eyes, Inc.	1997-07-07	160	0
K945110	KOLBERG OPHTHALMIC CONFORMER	Kolberg Ocular Products, Inc.	1995-01-13	87	0
K921221	STERILE/SINGLE USE SYMBLEPHARON RING	Storz Instrument Co.	1992-07-17	126	0
K921229	STERILE/SINGLE USE OPHTHALMIC CONFORMERS	Storz Instrument Co.	1992-06-09	88	0
K772168	MOLDEYE	Robert B. Scott Ocularists of Florida, Inc.	1977-11-30	22	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