Cuff-Able Plus
by Vital Signs, Inc. 510(k)
Active
510(k) K990412
Overview
The Cuff-Able Plus is a single‑use blood pressure cuff designed for non‑invasive arterial pressure measurement. It is constructed of the same material as the original Cuff-Able cuff and incorporates an antimicrobial agent to reduce the risk of microbial contamination during use.
The device is supplied as a sterile, disposable unit and is intended for single‑patient use only. It has received FDA 510(k) clearance (K990412) under product code DXQ and is classified as a Class II cardiovascular device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990412 | Date1 Sep 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- DXQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1120
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent