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

H & P Industries, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time

101 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K901217	TRIA-SONIC ULTRA SOUND TRANSMISSION GEL	H & P Industries, Inc.	1990-06-22	101	0
K871169	LUBRICATING JELLY	H & P Industries, Inc.	1987-04-01	8	2
K860961	GAMMA RADIATION STERILIZED ALCOHOL PREP PADS	H & P Industries, Inc.	1986-04-09	27	0
K830394	PROVIDONE-IODINE PREP-PADS & TOWELETTES	H & P Industries, Inc.	1983-04-06	58	0
K830393	PROVIDONE-IODINE SWABSTICKS	H & P Industries, Inc.	1983-04-06	58	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