510(k) · Cleared

Recalled · 2010

Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk Packages

K023479510(k) TraditionalCleared Nov 26, 200240-day reviewClass II21 CFR 884.5470Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

First Quality Hygienic, Inc. · HEB Tampon, Menstrual, Unscented

Cleared on Nov 26, 2002 as substantially equivalent to K896994 (Kimberly-Clark Corp., 1989) after a 40-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it. It has been recalled once.

Decided: Nov 26, 2002
Review: 40 days
Class: Class II
Product code: HEB
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K896994 (1989). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK896994 Kotex Security Tampons (Several Type)Kimberly-Clark Corp. · 1989 · Recalled
This deviceK023479 Femtex Tampons and Other Private Label Plastic Applicator Tampons…First Quality Hygienic, Inc. · 2002
Descendant · cites it directly · 0 of its ownK050660 Femtex and Private Label Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all

K050660Femtex and Private Label Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K896994	Kotex Security Tampons (Several Type)	Kimberly-Clark Corp.	1989	1
0 (this device)	K023479	Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer…	First Quality Hygienic, Inc.	2002	—
+1	K050660	Femtex and Private Label Plastic Applicator Tampons	First Quality Hygienic, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K023479, 1989–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HEB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HEB device

#1 K251033 Unscented menstrual long applicator tampon…score 14.3 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K896994	Kotex Security Tampons (Several Type) Summary page 2 …s tampons Manufacturer First Quality Hygien.. Kimberly Clark 510 (k) # requested K896994 Intended Use Absorb Menses Absorb Menses Intravaginally…	Kimberly-Clark Corp.	1989	1

Also cleared against K896994: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050660	Femtex and Private Label Plastic Applicator Tampons	First Quality Hygienic, Inc.	2005	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 25, 2010	Not classified	Z-2466-2010	Labeling mix-ups	Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons package contained Super Plus Unscented Plastic Applicator Tampons.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K050660 (First Quality Hygienic, Inc., 2005) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K896994.

How does its category compare?

All HEB devices

HEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HEB

6in 2025

2007high 7 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HEB

82in 2025

2007high 182 (2019) · low 28 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HEB

29in 2025

2007high 29 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HEB

452in 2025

2007high 3,034 (2019) · low 30 (2009)2025

MAUDE reports naming product code HEB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	38
2008	1	—	0	31
2009	7	136	0	30
2010	3	76	1	138
2011	3	28	1	291
2012	3	114	0	416
2013	2	—	0	259
2014	4	173	0	167
2015	5	114	0	132
2016	1	—	0	101
2017	2	—	0	194
2018	5	140	4	363
2019	7	182	0	3,034
2020	2	—	0	1,714
2021	6	60	0	1,403
2022	3	81	0	1,055
2023	5	109	0	702
2024	2	—	0	534
2025	6	82	29	452
2026	1	—	0	—

What is it indicated for?

First Quality Hygienic plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023479 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023479: Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk Packages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023479

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026