# K961401: HP Cathstation - Model M1264B

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard Co.
- Decided: Oct 8, 1996 after 180 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903771 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903771: HP Model M1008B, Noninvasive Blood Pressure Module, Hewlett-Packard Co. (1991) Summary page 1.

## Indications for use
As for the current HP Cathstation, the added NBP module is intended for use in the cardiac cath lab on adult, pediatric, and neonatal patients undergoing cardiac cath procedures. The intended use for the HP Cathstation NBP module is the same as the intended use for the legally marketed predicate device and several other products currently on the market. Other aspects of this modification are also consistent with the predicate device. This modification adds established NBP measurement and reporting capabilities to the HP Cathstation, providing additional information to clinicians in the cath lab.

Source page: https://510kreport.com/device/K961401
Methodology: https://510kreport.com/methodology