# K122058: Flexiport Ecocuff

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Nov 5, 2012 after 115 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K790810 (1979). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070060: Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood Pressure Cuff (One-Piece), Welch Allyn, Inc. (2007) Summary page 1.

## Indications for use
The Flexiort Ecouff Blood Pressure Cuff is intended to be used on the upper arm in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and is available in pediatric through adult sizes. The device is not intended for neonatal applications. The Flexiport Ecouff blood pressure cuff is not designed, sold or intended for use, except as indicated. This product is available for sale only upon the order of a physician or licensed health care professional.

Source page: https://510kreport.com/device/K122058
Methodology: https://510kreport.com/methodology