NXAClass II

Tracheotomy Care Kit

21 CFR 868.5800 / Anesthesiology

NXA is the FDA product code for Tracheotomy Care Kit, a class II device type, regulated under 21 CFR 868.5800. FDA's definition for this code 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 guidance above, is under enforcement discretion, and does not require a premarket...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1985-01-18, and 12 recalls.

Classification record

Product code: NXA
Device name: Tracheotomy Care Kit
FDA definition: 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 guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Regulation: 21 CFR 868.5800
Device class: Class II
Review panel: Anesthesiology
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 12

Clearances, product code NXA

By decision year

1 clearance under product code NXA with a decision year between 1985 and 1985, 1985 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NXA by decision year
Year	Clearances
1985	1

Applicants with the most clearances

Product code NXA

Applicants holding the most 510(k) clearances under product code NXA
Applicant	Clearances
Washington-Greene County Branch Pennsylvania Assoc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order