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

Pascal Co., Inc. — Predicate Candidate Screening

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

83 daysmedian FDA review time

637 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K102526	BLO2X OXYGEN BLOCKER	Pascal Co., Inc.	2010-10-22	50	0
K090597	FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH	Pascal Co., Inc.	2009-03-16	11	0
K040988	ZIRCON-F PROPHYLAXIS PASTE	Pascal Co., Inc.	2004-07-07	83	0
K040661	RADENT PROPHY PASTE	Pascal Co., Inc.	2004-06-09	89	0
K012889	BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT	Pascal Co., Inc.	2003-05-27	637	1
K030488	FLUORILAQ	Pascal Co., Inc.	2003-05-02	77	0
K912632	OCCLUDE	Pascal Co., Inc.	1992-01-17	217	0
K911259	HYDENT	Pascal Co., Inc.	1991-06-06	76	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