Port-Neb
by Medic-Aid, Ltd. 510(k)
Active
510(k) K971933
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971933 | Date1 Aug 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CAF
- FDA applicant
- Medic-Aid , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Port-Neb is an Anesthesiology device with product code CAF. It is classified as a Class 2 device. The device is manufactured by Medic-Aid, Ltd.
The Port-Neb is supplied by Medic-Aid, Ltd. and has been cleared through the Traditional 510(k) pathway. It has an FDA 510(k) clearance with the k number K971933. The device was cleared on August 1, 1997, after a 66-day FDA review.
Other devices from Medic-Aid, Ltd.
Questions
AI-generated answers, 25 Sep 2026
What is the Port-Neb device used for?
The Port-Neb is an anesthesiology device, indicating its use in medical procedures related to anesthesia.
How was the Port-Neb device cleared?
The Port-Neb was cleared through the Traditional 510(k) pathway, receiving FDA 510(k) clearance with the k number K971933.
What is the regulatory classification of the Port-Neb device?
The Port-Neb is classified as a Class 2 device, indicating a moderate level of risk and regulatory control.