510(k) Report

510(k) · Cleared

Cleared

Cotton Swabs

K820962510(k) TraditionalCleared Apr 20, 198214-day reviewClass I21 CFR 880.6025

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

Dafoe & Dafoe, Inc. · KXF Applicator, Absorbent Tipped, Non-Sterile

Cleared on Apr 20, 1982 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 20, 1982
Review
14 days
Class
Class I
Product code
KXF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K820962Source: FDA 510(k) database · 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 KXF? 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?

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.

How does its category compare?

All KXF devices

KXF Applicator, Absorbent Tipped, Non-Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXF

1in 2012

2011: 12012: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXF

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

Recalls per year · KXF

No recall names KXF since 2007.

Adverse event reports per year · KXF

5in 2025

2007: 112008: 132009: 72010: 152011: 422012: 372013: 342014: 142015: 62016: 112017: 182018: 92019: 102020: 642021: 1342022: 132023: 92024: 52025: 5
2007high 134 (2021) · low 5 (2024)2025

MAUDE reports naming product code KXF, 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
20070—011
20080—013
20090—07
20100—015
20111—042
20121—037
20130—034
20140—014
20150—06
20160—011
20170—018
20180—09
20190—010
20200—064
20210—0134
20220—013
20230—09
20240—05
20250—05
20260—0—

More from Dafoe & Dafoe, Inc.

4 FDA decisions under this applicant name. See the company

  • K820960Maxi & Mini ShieldsDafoe & Dafoe, Inc. · 1982
  • K820961Incontinence Pad or Adult DiaperDafoe & Dafoe, Inc. · 1982
  • K800747Beltless Maxi, Mini & Super Maxi PadsDafoe & Dafoe, Inc. · 1980

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The KXF category page

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https://510kreport.com/device/K820962 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820962: Cotton Swabs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820962

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