Medical Device
Manufacturing
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K844051Substantially Equivalent

Skilcraft - Tracheotomy Care Kit 3 Compartment

Washington-Greene County Branch Pennsylvania Assoc, Washington PA / Traditional, Substantially Equivalent

K844051 is the FDA 510(k) clearance record for SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT, a class II device, cleared for Washington-Greene County Branch Pennsylvania Assoc on under FDA product code NXA (Tracheotomy Care Kit). FDA's definition for product code NXA reads: "This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the...". FDA records list 3 510(k) clearances for Washington-Greene County Branch Pennsylvania Assoc, from to . As of , FDA records show no recalls naming K844051.

Clearance record

Decision date
Received
(93 days to decision)
Product code
NXA Tracheotomy Care Kit
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Washington-Greene County Branch Pennsylvania Assoc 566 E. Maiden St., Washington PA
Third party review
No

Clearances, product code NXA

Trailing 12 months

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

FDA records show no clearances under product code NXA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NXA, 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