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

First Quality Hygienic, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time

154 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K161877	Opal by Femtex Pull & Snap and Private Label Unscented Compa	First Quality Hygienic, Inc.	2016-08-05	28	0
K151470	Opal by Femtex and Private Label Unscented Compact Applicato	First Quality Hygienic, Inc.	2015-11-02	154	0
K051446	FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICAT	First Quality Hygienic, Inc.	2005-07-14	42	0
K050660	FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS	First Quality Hygienic, Inc.	2005-05-12	58	0
K050067	FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS	First Quality Hygienic, Inc.	2005-02-01	20	0
K032173	FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS	First Quality Hygienic, Inc.	2003-09-03	49	0
K031067	FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS	First Quality Hygienic, Inc.	2003-07-14	101	0
K023479	FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TA	First Quality Hygienic, Inc.	2002-11-26	40	1
K963034	FEMTEX GENTLE TOUCH TAMPONS	First Quality Hygienic, Inc.	1996-11-01	88	0
K963032	FREE CHOICE	First Quality Hygienic, Inc.	1996-10-11	67	0
K920238	PRIVATE LABELS AND FEMTEX	First Quality Hygienic, Inc.	1993-08-02	563	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