510(k) Report

510(k) · Cleared

Cleared

Ophthasonic a-Scan/ B-Scan

K871536510(k) TraditionalCleared Aug 26, 1987128-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

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

Cleared on Aug 26, 1987 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it.

Decided
Aug 26, 1987
Review
128 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

22 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2003: 1 descendant cleared2007: 1 descendant cleared2013: 2 descendants cleared2009: 1 descendant cleared2015: 3 descendants cleared2025: 3 descendants cleared2011: 1 descendant cleared2014: 1 descendant cleared2010: 1 descendant cleared2019: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK871536 Ophthasonic a-Scan/ B-ScanTeknar, Inc. · 1987
  2. Descendant · cites it directly · 21 of its ownK960765 Mentor Advent a/B SystemMentor Ophthalmics, Inc. · 1996
  3. Descendant · 2 generations on · 17 of its ownK032956 Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003
  4. Descendant · 3 generations on · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
  5. Descendant · 4 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
  6. Descendant · 5 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

1996: 12003: 12007: 12009: 12010: 12011: 12013: 22014: 12015: 32016: 12017: 12018: 12019: 22020: 12021: 12025: 3
1996high 3 (2015) · low 0 (1997)2026

Most influential descendants

Showing 5 of 22 · See all
  • K960765Mentor Advent a/B SystemMentor Ophthalmics, Inc. · 1996 · cites it directly21descendants
  • K032956Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003 · 2 generations on17descendants
  • K082891Lenstar, Model LS900Haag-Streit AG · 2009 · 3 generations on14descendants
  • K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 4 generations on10descendants
  • K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K871536Ophthasonic a-Scan/ B-ScanTeknar, Inc.1987—
+1K960765Mentor Advent a/B SystemMentor Ophthalmics, Inc.1996—
+2K032956Accusonic a-Scan Model, 24-4000Accutome, Inc.2003—
+3K082891Lenstar, Model LS900Haag-Streit AG20093
+4K101182Iolmaster 500Carl Zeiss Meditec, AG20104
+5K122418Iolmaster 500Carl Zeiss Meditec, AG20134

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200310
200710
200910
201010
201110
201320
201410
201530
201610
201710
201810
201920
202010
202110
202530
FIG. 1 — Lineage of K871536, 1987–2025Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960765Mentor Advent a/B SystemMentor Ophthalmics, Inc.199621

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, K960765 (Mentor Ophthalmics, Inc., 1996) has gone furthest, with 21 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 Teknar, Inc.

18 FDA decisions under this applicant name. See the company

  • K903666Ophthasonic a/P IiiTeknar, Inc. · 1990
  • K896038B-Scan 10 MHZ ProbeTeknar, Inc. · 1990
  • K896150Image 2000 System, Imaging, Ultra-SonicTeknar, Inc. · 1990
  • K891777Pro-Cut Biopsy NeedleTeknar, Inc. · 1989
  • K883965Probe, Imaging, Ultrasonic, Mechanical SectorTeknar, Inc. · 1988

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https://510kreport.com/device/K871536 · printed Nov 5, 2026

Cite this page

510(k) Report. “K871536: Ophthasonic a-Scan/ B-Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871536

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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