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

Alden Optical Labs., Inc. — Predicate Candidate Screening

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

69 daysmedian FDA review time

416 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K133079	IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR	Alden Optical Labs., Inc.	2013-12-17	78
K102557	NOVAKONE SPHERICAL AND TORIC LENSES	Alden Optical Labs., Inc.	2011-04-26	231
K091327	ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54	Alden Optical Labs., Inc.	2010-06-25	416
K052703	ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC),	Alden Optical Labs., Inc.	2005-11-10	43
K042242	ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES	Alden Optical Labs., Inc.	2004-09-15	27
K983278	OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAIL	Alden Optical Labs., Inc.	1998-11-25	69
K983053	ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR	Alden Optical Labs., Inc.	1998-10-21	50
K981252	OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR	Alden Optical Labs., Inc.	1998-06-23	78
K980554	ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DA	Alden Optical Labs., Inc.	1998-04-07	53
K973967	AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTAC	Alden Optical Labs., Inc.	1997-12-08	52

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