# K122365: Ultracheck Curve Blood Pressure Cuffs

- Pathway: 510(k) (Traditional)
- Applicant: Statcorp Medical
- Decided: Jun 4, 2013 after 302 days
- Product code: OED (Antimicrobial 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: 2 generations back to K884421 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071885: Antimicrobial and Single-Patient Cuffs, Philips Medical Systems (2007) Summary page 2.
- K954282: Ultracuff Blood Pressure Cuff and Inflation Bag, Statcorp, Inc. (1996) Summary page 1.

## Indications for use
UltraCheck® Curve Blood Pressure Cuffs are used with identified devices intended for the non-invasive measurement of adult human blood pressure. UltraCheck® Blood Pressure Cuffs are intended for use by or under the supervision of qualified medical personnel.

Source page: https://510kreport.com/device/K122365
Methodology: https://510kreport.com/methodology