# K012455: Welch Allyn Durashock Blood Pressure System

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Aug 17, 2001 after 16 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Welch Allyn, Tycos® Econo Blood Pressure Sphygmomanometer: named in the summary without a submission number

## Recalls of this device
- Mar 21, 2025 · Class II · Z-1567-2025: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

## Indications for use
The DuraShock™ Blood Pressure System-is intended for the non-invasive blood pressure measurement of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated. The Welch Allyn® DuraShock™ Blood Pressure System is not designed for use with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn® DuraShock™ child is the smallest cuff approved for use with children and infants whose arm circumference fit within the range markings on the cuff.

Source page: https://510kreport.com/device/K012455
Methodology: https://510kreport.com/methodology