510(k) Report

510(k) · Cleared

Cleared

Aplicare Skin Protectant Swabstick

K861558510(k) TraditionalCleared Jun 4, 198640-day reviewClass I21 CFR 880.5090

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

Aplicare, Inc. · NEC Bandage, Liquid, Skin Protectant

Cleared on Jun 4, 1986 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 4, 1986
Review
40 days
Class
Class I
Product code
NEC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K861558Source: 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 NEC? 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 NEC devices

NEC Bandage, Liquid, Skin Protectant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NEC

FDA has decided no NEC device since 2007.

Median 510(k) review, days · NEC

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

Recalls per year · NEC

1in 2018

2011: 12018: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · NEC

7in 2025

2007: 12010: 12011: 302012: 12013: 62014: 52015: 72016: 22017: 22019: 12020: 52021: 72022: 52024: 82025: 7
2007high 30 (2011) · low 0 (2008)2025

MAUDE reports naming product code NEC, 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—01
20080—00
20090—00
20100—01
20110—130
20120—01
20130—06
20140—05
20150—07
20160—02
20170—02
20180—10
20190—01
20200—05
20210—07
20220—05
20230—00
20240—08
20250—07
20260—0—

More from Aplicare, Inc.

9 FDA decisions under this applicant name. See the company

  • K923299Aplicare One Compund Benzion Tincture SwabstickAplicare, Inc. · 1994
  • K895039Sterile Saline - for Suction Catheter LubricationAplicare, Inc. · 1989
  • K873563Aplicare Sterile Water - for Suction Catheter OnlyAplicare, Inc. · 1987
  • K861557Aplicare Skin Protectant Prep PadAplicare, Inc. · 1986
  • K833185Acetone Alcohol Prep PadAplicare, Inc. · 1983

Recent decisions in NEC

The NEC category page

  • K972081SuperskinMedlogic Global Corp. · 1997
  • K861557Aplicare Skin Protectant Prep PadAplicare, Inc. · 1986

https://510kreport.com/device/K861558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K861558: Aplicare Skin Protectant Swabstick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861558

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