# K070060: Welch Allyn Flexiport Disposable Blood Pressure Cuff (One-Piece); Reusable Blood Pressure Cuff (One-Piece)

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Dec 18, 2007 after 347 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K790810 (1979). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974080: Critikon Soft Blood Pressure Cuff, Johnson & Johnson Medical, Inc. (1998) Summary page 1.
- K022482: Sensa-Cuff, Models Infant, Child, Adult, Ge Medical Systems Information Technologies (2002) Summary page 1.

## Most influential descendants
- K251745: Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (2025), 0 descendants of its own
- K122058: Flexiport Ecocuff (2012), 0 descendants of its own

## Recalls of this device
- Mar 21, 2025 · Class II · Z-1568-2025: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

## Indications for use
The FlexiPort Blood Pressure Cuff is used 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 Blood Pressure Cuffs are not designed, sold, or intended for use, except as indicated.

Source page: https://510kreport.com/device/K070060
Methodology: https://510kreport.com/methodology