Tracheostomy And Nasal Suctioning Kit
The Tracheostomy and Nasal Suctioning Kit is a prepackaged, sterile convenience kit containing the supplies necessary to perform suctioning of tracheostomy sites or nasal passages, established in accordance with the May 20, 1997 FDA guidance on convenience kits interim regulatory guidance. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRQ; no specific regulation number is on file, and the medical specialty is not categorized. No special flags apply to this device.
Basic Information
- Product Code
- LRQ
- Device Class
- FDA class 1
- Medical Specialty
- Unknown
- Review Panel
- SU
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963720 | TRACHEOSTOMY KIT | Nov 27, 1996 | Substantially Equivalent | Grand Medical Products |
| K961167 | MEDCARE TRACHEOSTOMY CARE TRAY | Jul 02, 1996 | Unknown | Medcare Medical Group, Inc. |
| K952925 | READY NURSE SYSTEM (RNS) TRACH CARE KIT | Jul 12, 1995 | Unknown | Contour Fabricators of Florida, Inc. |
| K950851 | GENT-L-KARE TRACHEOSTOMY TRAYS | Jun 21, 1995 | Substantially Equivalent | Premium Plastics, Inc. |
| K871692 | TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 | Jun 01, 1987 | Substantially Equivalent | Automatic Liquid Packaging, Inc. |
| K862663 | TRACHEOSTOMY CARE TRAY | Jul 30, 1986 | Substantially Equivalent | Welmed Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.