510(k) Report

510(k) · Cleared

Cleared

Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-a

K953530510(k) TraditionalCleared Apr 8, 1996256-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

Biosound, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Apr 8, 1996 as substantially equivalent to K896356 (Esaote Biomedica Spa, 1990) and 2 other predicates after a 256-day review. Its family tree reaches back 1 generation to 1990.

Decided
Apr 8, 1996
Review
256 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K896356 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1992: 1 other ancestorK896356 · AU530 Diagnostic Ultrasonic Pulsed Echo System · Esaote Biomedica Spa · 199019901992199419961998
Other ancestors, by generation 1 generation back: 2 other ancestors K896356 · AU530 Diagnostic Ultrasonic Pulsed Echo System · Esaote Biomedica Spa · 19900
  1. Root · 1 generation backK896356 AU530 Diagnostic Ultrasonic Pulsed Echo SystemEsaote Biomedica Spa · 1990
  2. This deviceK953530 Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-aBiosound, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K896356AU530 Diagnostic Ultrasonic Pulsed Echo SystemEsaote Biomedica Spa1990—
0 (this device)K953530Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-aBiosound, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199510
FIG. 1 — Lineage of K953530, 1990–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 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. #1 K243937 Accuro 3Sscore 20.5 · 18 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? (4)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK836356Esaote P10 Diagnostic Ultrasound Transducer
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 2
…eness Summeary Diagnostic Ultrasound Transducers, P10A, P124, PT10A, PAl1-A Biosound, Inc. "N7.92(a)(3) Predicate Device(s) Esaote P10 Diagnotic Ultrasound Transducer K836356 Esaote P12 Diagnotic Ultrasound Transducer K896356 Esaote SMA26 Diagnostic Ultrasound Transducer K944485/S3 Acuson S228 Diagnos…
*K896356AU530 Diagnostic Ultrasonic Pulsed Echo System
Summary page 2
…0A, P124, PT10A, PAl1-A Biosound, Inc. "N7.92(a)(3) Predicate Device(s) Esaote P10 Diagnotic Ultrasound Transducer K836356 Esaote P12 Diagnotic Ultrasound Transducer K896356 Esaote SMA26 Diagnostic Ultrasound Transducer K944485/S3 Acuson S228 Diagnostic Ultrasound Transducer K902515 Additional Substa…
Esaote Biomedica Spa1990—
*K9444854000 AU Ultrasound Imaging System
Summary page 2
…redicate Device(s) Esaote P10 Diagnotic Ultrasound Transducer K836356 Esaote P12 Diagnotic Ultrasound Transducer K896356 Esaote SMA26 Diagnostic Ultrasound Transducer K944485/S3 Acuson S228 Diagnostic Ultrasound Transducer K902515 Additional Substantial Equivalence information is provided in the attach…
Biosound, Inc.1995—
*K902515Acuson S228 Transducer for Transcranial Color Dopp
Summary page 2
…sducer K836356 Esaote P12 Diagnotic Ultrasound Transducer K896356 Esaote SMA26 Diagnostic Ultrasound Transducer K944485/S3 Acuson S228 Diagnostic Ultrasound Transducer K902515 Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table. 807.92(a)(…
Acuson Corp.1992—

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 3 ancestors has a recall.

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

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
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

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

What is it indicated for?

The intended use is specific for each transducer: P12A - Vascular

PT10A - Transcranial

P10A - Cardiac

PA11A - Cardiac/ Transcranial

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

More from Biosound, Inc.

39 FDA decisions under this applicant name. See the company

  • K971700Biopsy Accessory for Ultrasound TransducerBiosound, Inc. · 1997
  • K963936Accesspoint, Med E-Mail, Dicom ReaderBiosound, Inc. · 1997
  • K963262Artoscan MBiosound, Inc. · 1997
  • K963662Galileo Evoked PotentialreBiosound, Inc. · 1997
  • K953716Intracavity TransducersBiosound, Inc. · 1996

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The IYO category page

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https://510kreport.com/device/K953530 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953530: Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953530

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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