510(k) Report

510(k) · Cleared

Cleared

Femtex and Private Label Opal Fresh Scented Plastic Applicator Tampons

K051446510(k) TraditionalCleared Jul 14, 200542-day reviewClass II21 CFR 884.5460

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. · HIL Tampon, Menstrual, Scented, Scented-Deodorized

Cleared on Jul 14, 2005 as substantially equivalent to K032173 (First Quality Hygienic, Inc., 2003) after a 42-day review. Its family tree reaches back 1 generation to 2003.

Decided
Jul 14, 2005
Review
42 days
Class
Class II
Product code
HIL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K032173 (2003). No later device cites it as a predicate yet.

K032173 · Femtex and Private Label Scented Plastic Applicator Tampons · First Quality Hygienic, Inc. · 20032000200220042006
K032173 · Femtex and Private Label Scented Plastic Applicator Tampons · First Quality Hygienic, Inc. · 20030
  1. Root · 1 generation backK032173 Femtex and Private Label Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2003
  2. This deviceK051446 Femtex and Private Label Opal Fresh Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K032173Femtex and Private Label Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc.2003—
0 (this device)K051446Femtex and Private Label Opal Fresh Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc.2005—
FIG. 1 — Lineage of K051446, 2003–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K032173Femtex and Private Label Scented Plastic Applicator Tampons
Summary page 1
…and Private Label Scented Plastic Applicator Tampons are substantially equivalent to legally marketed Femtex and Other Private label Scented Plastic Applicator tampons (1K032173). Device description: Femtex and Private Label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual…
First Quality Hygienic, Inc.2003—

Also cleared against K032173: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K032173.

How does its category compare?

All HIL devices

HIL Tampon, Menstrual, Scented, Scented-Deodorized: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIL

1in 2014

2007: 22008: 22012: 22013: 12014: 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIL

Too few HIL 510(k)s in any year since 2007 to give a median.

Recalls per year · HIL

No recall names HIL since 2007.

Adverse event reports per year · HIL

1in 2025

2007: 82008: 82009: 132010: 112011: 42012: 22013: 92014: 32015: 32016: 42017: 22018: 12019: 12020: 122021: 72022: 22023: 12024: 12025: 1
2007high 13 (2009) · low 1 (2018)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—08
20082—08
20090—013
20100—011
20110—04
20122—02
20131—09
20141—03
20150—03
20160—04
20170—02
20180—01
20190—01
20200—012
20210—07
20220—02
20230—01
20240—01
20250—01
20260—0—

What is it indicated for?

As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470).

First Quality Hygienic, Inc. Femtex and Private Label Scented plastic applicator tampons are a plug 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.

Also cleared against K032173

1 other device cites the same predicate.

  • K050067Femtex and Private Label Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005

More from First Quality Hygienic, Inc.

11 FDA decisions under this applicant name. See the company

  • K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull…First Quality Hygienic, Inc. · 2016
  • K151470Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and…First Quality Hygienic, Inc. · 2015
  • K050660Femtex and Private Label Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005
  • K050067Femtex and Private Label Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005
  • K032173Femtex and Private Label Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2003

Recent decisions in HIL

The HIL category page

  • K132208Ontex and Others Proprietary NamesOntex Bvba · 2014
  • K132819Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc. · 2013
  • K120245Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented TamponsPlaytex, Inc. · 2012
  • K111684Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc. · 2012
  • K081555Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co. · 20081 recall

https://510kreport.com/device/K051446 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051446: Femtex and Private Label Opal Fresh Scented Plastic Applicator Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051446

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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