# K911213: Cuffable

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Dynamics, Inc.
- Decided: Aug 7, 1991 after 141 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.
53 later devices descend from it; 4 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K974080: Critikon Soft Blood Pressure Cuff (1998), 51 descendants of its own
- K120364: Unimed Disposable Blood Pressure Cuff (2012), 23 descendants of its own
- K012194: Blood Pressure Monitor (Sphygmomanometer), Model HT-110 (2001), 14 descendants of its own
- K043286: Aneroid Sphygmomanometer, Model BK2002 (2005), 13 descendants of its own
- K173246: Aneroid Sphygmomanometer (2018), 10 descendants of its own

## Recalls of this device
- Apr 26, 2011 · Not classified · Z-2581-2011: BP cuffs may not properly inflate due to a leak

Source page: https://510kreport.com/device/K911213
Methodology: https://510kreport.com/methodology