FDA product code NXA: Tracheotomy Care Kit
NXA is the FDA product code for tracheotomy care kit. It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under NXA. The average 510(k) review took 93 days (median 93). FDA has posted 12 recalls for NXA devices, 9 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Tracheotomy Care Kit |
| Device class | Class II |
| Regulation | 21 CFR 868.5800 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NXA clearance
Top NXA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Washington-Greene County Branch Pennsylvania Assoc | 1 | 1985-01-18 |
Most recent NXA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844051 | Washington-Greene County Branch Pennsylvania Assoc | SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT | 1985-01-18 | 93 |
Recalls for NXA devices
12 product recalls in 11 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2026-01-07.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code NXA?
NXA is the FDA product code for tracheotomy care kit. It is a Class II device, regulated under 21 CFR 868.5800 and reviewed by the Anesthesiology panel.
What device class is NXA?
Class II, regulation 21 CFR 868.5800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NXA?
Across 1 cleared submissions the average was 93 days from receipt to decision (median 93).
Which companies have the most NXA clearances?
Washington-Greene County Branch Pennsylvania Assoc (1).
Have NXA devices been recalled?
Yes: 12 product recalls across 11 recall events; the most recent began 2026-01-07.
Next steps
- Run an FDA pathway report with predicate devices for product code NXA
- Run a recall and safety report across every NXA manufacturer
- Watch product code NXA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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