510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

HD15 Diagnostic Ultrasound System

K081661510(k) TraditionalCleared Jun 24, 200811-day reviewClass II21 CFR 892.1550Recalls 25

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

Philips Ultrasound, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jun 24, 2008 as substantially equivalent to K043535 (Philips Ultrasound, Inc., 2005) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 2003. It has been recalled 25 times.

Decided
Jun 24, 2008
Review
11 days
Class
Class II
Product code
IYN
Recalls
25
Predicates
2

Its longest line of descent runs back 2 generations to K031066 (2003). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestorK031066 · Viewmate Ultrasound Imaging System · Ep Medsystems · 2003K062247 · HD11 Diagnostic Ultrasound System · Philips Ultrasound, Inc. · 2006 · recalled200020022004200620082010
Other ancestors, by generation 1 generation back: 1 other ancestor K062247 · HD11 Diagnostic Ultrasound System · Philips Ultrasound, Inc. · 2006 · recalledK031066 · Viewmate Ultrasound Imaging System · Ep Medsystems · 20030
  1. Root · 2 generations backK031066 Viewmate Ultrasound Imaging SystemEp Medsystems · 2003
  2. 1 generation backK062247 HD11 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2006 · Recalled
  3. This deviceK081661 HD15 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K031066Viewmate Ultrasound Imaging SystemEp Medsystems2003—
−1K062247HD11 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.20063
0 (this device)K081661HD15 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K081661, 2003–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K043535HD11 Diagnostic Ultrasound System
Summary page 1
…e the image, a display screen, and a connection to the separate transducers. It is substantially equivalent to the currently marketed [DI 1 Diagnostic Ultrasound System (K043535 and K062247). Page 9 5 10O(k) Premarket Notification…
Philips Ultrasound, Inc.200536
*K062247HD11 Diagnostic Ultrasound System
Summary page 1
…a display screen, and a connection to the separate transducers. It is substantially equivalent to the currently marketed [DI 1 Diagnostic Ultrasound System (K043535 and K062247). Page 9 5 10O(k) Premarket Notification…
Philips Ultrasound, Inc.20063

Also cleared against K043535: 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)

Recalls of this device

DateClassRecallRoot causeReason
Sep 5, 2025Class IIIZ-1620-2026Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025Class IIIZ-1626-2026Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sep 5, 2025Class IIIZ-1624-2026Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2377-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2372-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2403-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2378-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2396-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2394-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2376-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2397-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2359-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2358-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2357-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2349-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2356-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2347-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2366-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025Class IIIZ-2353-2025Device DesignTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.
May 28, 2025Class IIZ-2048-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2050-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2054-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2062-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
May 28, 2025Class IIZ-2059-2025Process controlUltrasound transducer devices were refurbished beyond their useful life.
Jun 30, 2023Class IIZ-2517-2023Process controlTransducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in…

The 5 latest of 25 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K043535.

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. 2008, this device’s year, is highlighted.

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
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

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

What is it indicated for?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use as stated in the FDA summary.

Also cleared against K043535

3 other devices cite the same predicate.

  • K120321Clearvue 350/550 Diagnostic Ultrasound SystemPhilips Health Care · 20128 recalls
  • K111513CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 201110 recalls
  • K081802CX50 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 20084 recalls

More from Philips Ultrasound, Inc.

46 FDA decisions under this applicant name. See the company

  • K212777Collaboration LivePhilips Ultrasound, Inc. · 2021
  • K203406Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 20213 recalls
  • K200603AAA ModelPhilips Ultrasound, Inc. · 2020
  • K201665Collaboration LivePhilips Ultrasound, Inc. · 2020
  • K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc. · 20208 recalls

Recent decisions in IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K081661 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081661: HD15 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081661

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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