510(k) · Cleared

Cleared

Philips Sono Diagnost 800

K963706510(k) TraditionalCleared Mar 19, 1997184-day reviewClass II21 CFR 892.1560

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

Hewlett-Packard Co. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Mar 19, 1997 as substantially equivalent to K935923 (Hewlett-Packard Co., 1994) after a 184-day review. Its family tree reaches back 1 generation to 1994.

Decided: Mar 19, 1997
Review: 184 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935923 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK935923 Philips Ultrasound P800 Imaging SystemHewlett-Packard Co. · 1994
This deviceK963706 Philips Sono Diagnost 800Hewlett-Packard Co. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935923	Philips Ultrasound P800 Imaging System	Hewlett-Packard Co.	1994	—
0 (this device)	K963706	Philips Sono Diagnost 800	Hewlett-Packard Co.	1997	—

FIG. 1 — Lineage of K963706, 1994–1997Source: 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 IYO? 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 IYO device

#1 K243937 Accuro 3Sscore 20.5 · 18 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
*	K935923	Philips Ultrasound P800 Imaging System Summary page 1 …evice: The predicate device for this submittal is existing SD 800 human interface controls which were reviewed by FDA on the SD 800 system that was submitted as part of K935923. 4) Description of the device or modification being submitted for premarket approval. Functionaliiy: This SW modification allow…	Hewlett-Packard Co.	1994	—

Also cleared against K935923: 3 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.
3 other devices also cite its predicate K935923.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

https://510kreport.com/device/K963706 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963706: Philips Sono Diagnost 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963706

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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