510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861558Substantially Equivalent

Aplicare Skin Protectant Swabstick

Aplicare, Inc., Madison CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861558 is the FDA 510(k) clearance record for APLICARE SKIN PROTECTANT SWABSTICK, a class I device, cleared for Aplicare, Inc. on under FDA product code NEC (Bandage, Liquid, Skin Protectant). FDA records list 9 510(k) clearances for Aplicare, Inc., from to . As of , FDA records show no recalls naming K861558.

Clearance record

Decision date
Received
(40 days to decision)
Product code
NEC Bandage, Liquid, Skin Protectant
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Aplicare, Inc. 7 Orchard Park Rd., Madison CT
Third party review
No

Clearances, product code NEC

Trailing 12 months

FDA records hold no clearances under product code NEC in the trailing twelve months.

FDA records show no clearances under product code NEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NEC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260