510(k) Report

510(k) · Cleared

Cleared

Tampax Compak, Compact Plastic Appli. Regu. Tampon

K880023510(k) TraditionalCleared Mar 2, 198857-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

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

Cleared on Mar 2, 1988 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 2, 1988
Review
57 days
Class
Class II
Product code
HIL
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared1990200020102020
  1. This deviceK880023 Tampax Compak, Compact Plastic Appli. Regu. TamponTambrands, Inc. · 1988
  2. Descendant · cites it directly · 0 of its ownK062638 Tampax Compak Pearl Plastic Applicator Scented and Unscented TamponsProcter & Gamble Co. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K062638Tampax Compak Pearl Plastic Applicator Scented and Unscented TamponsProcter & Gamble Co. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K880023Tampax Compak, Compact Plastic Appli. Regu. TamponTambrands, Inc.1988—
+1K062638Tampax Compak Pearl Plastic Applicator Scented and Unscented TamponsProcter & Gamble Co.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K880023, 1988–2006Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

  • 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K062638Tampax Compak Pearl Plastic Applicator Scented and Unscented TamponsProcter & Gamble Co.20060

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?

  • Of its descendants, K062638 (Procter & Gamble Co., 2006) has gone furthest, with 0 descendants of its own.

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—

More from Tambrands, Inc.

70 FDA decisions under this applicant name. See the company

  • K962476Unscented Menstrual Tampon, Plastic ApplicatorTambrands, Inc. · 1996
  • K960341Tampax Tampon with Additive Junior,Regular,Super, and Super PlusTambrands, Inc. · 1996
  • K952344Satin Touch Deodorant Tampon Junior, Regular, Super, Super PlusTambrands, Inc. · 1995
  • K944834Unscented Menstrual TamponsTambrands, Inc. · 1994
  • K923932Tampax Tampons, Super AbsorbencyTambrands, Inc. · 1993

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/K880023 · printed Nov 6, 2026

Cite this page

510(k) Report. “K880023: Tampax Compak, Compact Plastic Appli. Regu. Tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880023

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026