Tracheotomy Care Kit
The Tracheotomy Care Kit (product code NXA) is a convenience kit used for the care and maintenance of tracheotomy sites, regulated under 21 CFR 868.5800 within the Anesthesiology specialty. As a Class 2 convenience kit under the May 1997 Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) if all guidance criteria are met. The device carries no implant or life-sustaining flags.
Research product code NXA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NXA
- Device Class
- FDA class 2
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 7
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K844051 | SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT | Jan 18, 1985 | Substantially Equivalent | Washington-Greene County Branch Pennsylvania Assoc |
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.