510(k) · Cleared

Cleared

HP Sonos 100CF Ultrasound Imaging System

K955327510(k) TraditionalCleared Apr 8, 1996140-day reviewClass II21 CFR 892.1550

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

Hewlett-Packard Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Apr 8, 1996 as substantially equivalent to K935923 (Hewlett-Packard Co., 1994) and 1 other predicate after a 140-day review. Its family tree reaches back 1 generation to 1994.

Decided: Apr 8, 1996
Review: 140 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K935923 (1994). 2 ancestors in all. 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 deviceK955327 HP Sonos 100CF Ultrasound Imaging SystemHewlett-Packard Co. · 1996

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)	K955327	HP Sonos 100CF Ultrasound Imaging System	Hewlett-Packard Co.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K955327, 1994–1996Source: 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 IYN? 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 IYN device

#1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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? (2)

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 …c Transducer Predicate Devices: In this 510(k) submission, the legally marketed devices to which we claim equivalence are the HP/Philips P800 Ultrasound Imaging System (K935923) and the Sharplan Usight 9010 Laparoscopic Ultrasound System (K945796). Device Description: This 510(k) submission is to add an…	Hewlett-Packard Co.	1994	—
*	K945796	Sharplan Usight 9010 Laparoscopic Ultrasound System Summary page 1 …y marketed devices to which we claim equivalence are the HP/Philips P800 Ultrasound Imaging System (K935923) and the Sharplan Usight 9010 Laparoscopic Ultrasound System (K945796). Device Description: This 510(k) submission is to add an endovaginal transducer and a new EV(EndoVaginal)/Pelvic study type to…	Sharplan Lasers, Inc.	1995	—

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?

None of the 2 ancestors has a recall.
3 other devices also cite its predicate K935923.

How does its category compare?

All IYN devices

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

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

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

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

What is it indicated for?

This modification expands the intended use statement for the HP SONOS 100CF Ultrasound Imaging System to include obstetrics and gynecology applications.

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/K955327 · printed Nov 5, 2026

Cite this page

510(k) Report. “K955327: HP Sonos 100CF Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955327

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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