510(k) · Cleared

Cleared

HP Cathstation - Model M1264B

K961401510(k) TraditionalCleared Oct 8, 1996180-day reviewClass II21 CFR 870.2340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hewlett-Packard Co. · DPS Electrocardiograph

Cleared on Oct 8, 1996 as substantially equivalent to K903771 (Hewlett-Packard Co., 1991) after a 180-day review. Its family tree reaches back 1 generation to 1991.

Decided: Oct 8, 1996
Review: 180 days
Class: Class II
Product code: DPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K903771 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK903771 HP Model M1008B, Noninvasive Blood Pressure ModuleHewlett-Packard Co. · 1991
This deviceK961401 HP Cathstation - Model M1264BHewlett-Packard Co. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903771	HP Model M1008B, Noninvasive Blood Pressure Module	Hewlett-Packard Co.	1991	—
0 (this device)	K961401	HP Cathstation - Model M1264B	Hewlett-Packard Co.	1996	—

FIG. 1 — Lineage of K961401, 1991–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DPS device

#1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K903771	HP Model M1008B, Noninvasive Blood Pressure Module Summary page 1 …hstation modification described in this 510(k) submission, the legally marketed devices to which we claim equivalence is the HP M1008B Noninvasive Blood Pressure module (K903 771) used with the HP Component Monitoring System. Device Description: The HP Cathstation is modified by the addition of the HP M100…	Hewlett-Packard Co.	1991	—

Also cleared against K903771: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
2 other devices also cite its predicate K903771.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007high 260 (2024) · low 31 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPS

3in 2025

2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	87	2	9
2008	13	31	0	17
2009	14	84	1	14
2010	11	104	2	21
2011	22	154	1	121
2012	12	117	0	56
2013	10	134	0	15
2014	11	253	0	15
2015	8	178	0	30
2016	11	229	0	12
2017	9	177	0	15
2018	14	221	0	19
2019	3	178	9	27
2020	6	224	2	59
2021	5	135	1	24
2022	6	244	1	59
2023	10	236	3	54
2024	8	260	4 (1)	64
2025	6	163	3	55
2026	6	258	4	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K961401 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961401: HP Cathstation - Model M1264B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961401

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026