510(k) Report

510(k) · Cleared

Cleared

B-Scan Opthalmic Ultrasound Imaging System

K926251510(k) TraditionalCleared Sep 14, 1993274-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

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

Cleared on Sep 14, 1993 after a 274-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 26 later devices descend from it.

Decided
Sep 14, 1993
Review
274 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

26 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2000: 1 descendant cleared2005: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared2010: 3 descendants cleared2006: 1 descendant cleared2019: 3 descendants cleared2015: 3 descendants cleared2014: 1 descendant cleared2025: 2 descendants cleared2013: 1 descendant cleared2018: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2021: 2 descendants cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK926251 B-Scan Opthalmic Ultrasound Imaging SystemBiovision, Inc. · 1993
  2. Descendant · cites it directly · 17 of its ownK993357 IolmasterCarl Zeiss, Inc. · 2000 · Recalled
  3. Descendant · 2 generations on · 16 of its ownK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
  4. Descendant · 2 generations on · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
  5. Descendant · 2 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
  6. Descendant · 3 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2000: 12002: 12003: 12005: 12006: 12009: 12010: 32013: 12014: 12015: 32016: 12017: 12018: 22019: 32020: 12021: 22025: 2
2000high 3 (2010) · low 0 (2001)2026

Most influential descendants

Showing 5 of 26 · See all
  • K993357IolmasterCarl Zeiss, Inc. · 2000 · cites it directly17descendants
  • K030393Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003 · 2 generations on16descendants
  • K082891Lenstar, Model LS900Haag-Streit AG · 2009 · 2 generations on14descendants
  • K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 2 generations on10descendants
  • K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926251B-Scan Opthalmic Ultrasound Imaging SystemBiovision, Inc.1993—
+1K993357IolmasterCarl Zeiss, Inc.20004
+2K030393Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG2003—
+2K082891Lenstar, Model LS900Haag-Streit AG20093
+2K101182Iolmaster 500Carl Zeiss Meditec, AG20104
+3K122418Iolmaster 500Carl Zeiss Meditec, AG20134

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
200310
200510
200610
200910
201030
201310
201410
201530
201610
201710
201820
201930
202010
202120
202520
FIG. 1 — Lineage of K926251, 1993–2025Source: 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 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K993357IolmasterCarl Zeiss, Inc.200017
K021683Cinescan SQuantel Medical20027

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, K993357 (Carl Zeiss, Inc., 2000) has gone furthest, with 17 descendants of its own.

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—

More from Biovision, Inc.

3 FDA decisions under this applicant name. See the company

  • K910027Crystal Focus Emerald Laser SLT MCX 1.5 Convex ProBiovision, Inc. · 1991
  • K901636Diamond ND:Yag Ophthalmic LaserBiovision, Inc. · 1990

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https://510kreport.com/device/K926251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926251: B-Scan Opthalmic Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926251

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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