# K974080: Critikon Soft Blood Pressure Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: May 18, 1998 after 201 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: 1 generation back to K790810 (1979). 5 ancestors in all.
51 later devices descend from it; 9 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790810: Disposa-Cuf, Crest Medical Equipment (1979) Summary page 2.
- K911213: Cuffable, Biomedical Dynamics, Inc. (1991) Summary page 2.
- K883977: Surgi-Cuf Sterile/Non-Sterile Disposable, Ethox Corp. (1989) Summary page 2.
- K921997: CUFF-M, Lorin Medical, Inc. (1992) Summary page 2.
- K940214: Statcorp Inc. Disposable Blood Pressure Cuff, Statcorp, Inc. (1994) Summary page 2.
- (no number) Safe-Cuff Cuff: named in the summary without a submission number

## Most influential descendants
- 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
- K190902: RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope (2019), 9 descendants of its own

## Recalls of this device
- Oct 24, 2000 · Not classified · Z-1236-03: Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.

## Indications for use
The CRITIKON Soft Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The device is non-sterile and semi-disposable (may be single-patient use or optional limited reuse). It is available in neonatal, pediatric and adult sizes. The device is not designed, sold, or intended for use except as indicated.

Source page: https://510kreport.com/device/K974080
Methodology: https://510kreport.com/methodology