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

Blublocker Corp. — Predicate Candidate Screening

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

49 daysmedian FDA review time

93 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K954659	MOONSHADES SUNGLASSES	Blublocker Corp.	1996-01-11	93
K950807	SUNBLOCKER SUNGLASSES	Blublocker Corp.	1995-05-24	91
K901160	NUBALOO(R) SUNGLASSES	Blublocker Corp.	1990-06-14	93
K901161	SOLAR SHADES(TM) SUNGLASSES	Blublocker Corp.	1990-05-01	49
K900382	BLUBLOCKER SUNGLASSES	Blublocker Corp.	1990-02-13	19
K900381	COLORVISION SUNGLASSES	Blublocker Corp.	1990-02-13	19
K900383	BULLET SUNGLASSES	Blublocker Corp.	1990-02-13	19

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