# K051904: All Purpose Cuff, Model 222APC

- Pathway: 510(k) (Abbreviated)
- Applicant: Suntech Medical, Inc.
- Decided: Sep 9, 2005 after 58 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
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) CRITIKON DURA-CUF® Blood Pressure Cuff: named in the summary without a submission number
- (no number) Cuff accessory for the Oscar 2 Oscillometric Ambulatory BP Recorder: named in the summary without a submission number

## Indications for use
The All Purpose Cuff is intended to be used with a manual or automatic non-invasive sphygmomanometer to determine blood pressure parameters on pediatric and adult patients. They are not intended to be used on neonates. They are intended to be used with prescription (clinical grade) blood pressure monitors; they also could be used with Over-The-Counter (home) blood pressure monitors.

Source page: https://510kreport.com/device/K051904
Methodology: https://510kreport.com/methodology