# K032821: Hygia Health Services Reprocessed Blood Pressure Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: Dec 5, 2003 after 91 days
- Product code: NPP (Reprocessed 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 K790810 (1979). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974080: Critikon Soft Blood Pressure Cuff, Johnson & Johnson Medical, Inc. (1998) Summary page 1.
- K790810: Disposa-Cuf, Crest Medical Equipment (1979) Summary page 1.
- K883977: Surgi-Cuf Sterile/Non-Sterile Disposable, Ethox Corp. (1989) Summary page 1.
- K911213: Cuffable, Biomedical Dynamics, Inc. (1991) Summary page 1.
- K940214: Statcorp Inc. Disposable Blood Pressure Cuff, Statcorp, Inc. (1994) Summary page 1.
- K942259: Technicuff, Technicuff Corp. (1994) Summary page 1.
- K002360: Cloud Cuff, Parts Port, Ltd. (2000) Summary page 1.

## Indications for use
The Hygia Health Services Reprocessed Blood Pressure Cuff is an accessory used by trained personnel in conjunction with non-invasive blood pressure measurement systems, primarily in a clinical setting.

Source page: https://510kreport.com/device/K032821
Methodology: https://510kreport.com/methodology