510(k) Report

510(k) · Cleared

Cleared

Ophthasonic a/P Iii

K903666510(k) TraditionalCleared Nov 19, 199097-day reviewClass I21 CFR 886.4250

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

Teknar, Inc. · HPY Unit, Electrolysis, Battery-Powered, Ophthalmic

Cleared on Nov 19, 1990 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.

Decided
Nov 19, 1990
Review
97 days
Class
Class I
Product code
HPY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2013: 2 descendants cleared2009: 1 descendant cleared2014: 1 descendant cleared2025: 2 descendants cleared2015: 3 descendants cleared2010: 1 descendant cleared2019: 2 descendants cleared2017: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK903666 Ophthasonic a/P IiiTeknar, Inc. · 1990
  2. Descendant · cites it directly · 17 of its ownK032956 Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003
  3. Descendant · 2 generations on · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
  4. Descendant · 3 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
  5. Descendant · 4 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
  6. Descendant · 3 generations on · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2003: 12009: 12010: 12013: 22014: 12015: 32016: 12017: 12018: 12019: 22020: 12021: 12025: 2
2003high 3 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 18 · See all
  • K032956Accusonic a-Scan Model, 24-4000Accutome, Inc. · 2003 · cites it directly17descendants
  • K082891Lenstar, Model LS900Haag-Streit AG · 2009 · 2 generations on14descendants
  • K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 3 generations on10descendants
  • K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 4 generations on9descendants
  • K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903666Ophthasonic a/P IiiTeknar, Inc.1990—
+1K032956Accusonic a-Scan Model, 24-4000Accutome, Inc.2003—
+2K082891Lenstar, Model LS900Haag-Streit AG20093
+3K101182Iolmaster 500Carl Zeiss Meditec, AG20104
+4K122418Iolmaster 500Carl Zeiss Meditec, AG20134
+3K143275IOLMaster700Carl Zeiss Meditec, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200910
201010
201320
201410
201530
201610
201710
201810
201920
202010
202110
202520
FIG. 1 — Lineage of K903666, 1990–2025Source: 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 HPY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K032956Accusonic a-Scan Model, 24-4000Accutome, Inc.200317

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, K032956 (Accutome, Inc., 2003) has gone furthest, with 17 descendants of its own.

How does its category compare?

All HPY devices

HPY Unit, Electrolysis, Battery-Powered, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HPY

FDA has decided no HPY device since 2007.

Median 510(k) review, days · HPY

Too few HPY 510(k)s in any year since 2007 to give a median.

Recalls per year · HPY

No recall names HPY since 2007.

Adverse event reports per year · HPY

No MAUDE report names HPY since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Teknar, Inc.

18 FDA decisions under this applicant name. See the company

  • 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
  • K881850Teknar Percu-ScanTeknar, Inc. · 1988

https://510kreport.com/device/K903666 · printed Nov 6, 2026

Cite this page

510(k) Report. “K903666: Ophthasonic a/P Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903666

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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