510(k) Report

510(k) · Cleared

Cleared

Diagnostic Ultrasound System Type 3535

K905198510(k) TraditionalCleared Aug 28, 1991281-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

Bruel & Kjaer · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Aug 28, 1991 after a 281-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Aug 28, 1991
Review
281 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

12 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1999: 2 descendants cleared1998: 2 descendants cleared2003: 2 descendants cleared2013: 2 descendants cleared2008: 1 descendant cleared2017: 1 descendant cleared1990200020102020
  1. This deviceK905198 Diagnostic Ultrasound System Type 3535Bruel & Kjaer · 1991
  2. Descendant · cites it directly · 6 of its ownK972672 Brachystepper Stepping Unit, Brachystepper Needle Guide Template…Barzell-Whitmore Maroon Bells, Inc. · 1997
  3. Descendant · 2 generations on · 1 of its ownK131161 EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper…CIVCO Medical Instruments Co., Inc. · 2013
  4. Descendant · cites it directly · 1 of its ownK992152 General Purpose Transducer Standoff, Biopsy Transducer Standoff…CIVCO Medical Instruments Co., Inc. · 1999
  5. Descendant · 2 generations on · 1 of its ownK982696 InterplantBurdette Medical Systems, Inc. · 1999 · Recalled
  6. Descendant · cites it directly · 1 of its ownK972192 Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc. · 1997

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

1997: 21998: 21999: 22003: 22008: 12013: 22017: 1
1997high 2 (1997) · low 0 (2000)2026

Most influential descendants

Showing 5 of 12 · See all
  • K972672Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support…Barzell-Whitmore Maroon Bells, Inc. · 1997 · cites it directly6descendants
  • K131161EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…CIVCO Medical Instruments Co., Inc. · 2013 · 2 generations on1descendant
  • K992152General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity…CIVCO Medical Instruments Co., Inc. · 1999 · cites it directly1descendant
  • K982696InterplantBurdette Medical Systems, Inc. · 1999 · 2 generations on1descendant
  • K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc. · 1997 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905198Diagnostic Ultrasound System Type 3535Bruel & Kjaer1991—
+1K972672Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand…Barzell-Whitmore Maroon Bells, Inc.1997—
+2K131161EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…CIVCO Medical Instruments Co., Inc.2013—
+1K992152General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane…CIVCO Medical Instruments Co., Inc.1999—
+2K982696InterplantBurdette Medical Systems, Inc.19991
+1K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199820
199920
200320
200810
201320
201710
FIG. 1 — Lineage of K905198, 1991–2017Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (12)

See all 12

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972672Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support…Barzell-Whitmore Maroon Bells, Inc.19976
K992152General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity…CIVCO Medical Instruments Co., Inc.19991
K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc.19971
K980997PGK Device (Modified)Pgk, Inc.19980

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?

  • Of its descendants, K972672 (Barzell-Whitmore Maroon Bells, Inc., 1997) has gone furthest, with 6 descendants of its own.

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

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)—

More from Bruel & Kjaer

4 FDA decisions under this applicant name. See the company

  • K925484Carbon Dioxide & Oxygen Monitor Type 1308Bruel & Kjaer · 1993
  • K914295Anesthetic Gas Monitor Type 1304, ModifiedBruel & Kjaer · 1992
  • K911348Rigid EndoscopeBruel & Kjaer · 1991

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/K905198 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905198: Diagnostic Ultrasound System Type 3535.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905198

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026