510(k) Report

510(k) · Cleared

Cleared

Optical Zone/Hexagonal/Astigmatism/Radial Markers

K925606510(k) TraditionalCleared Aug 29, 1994662-day reviewClass I21 CFR 886.4570

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

Chiron Vision Corp. · HMR Marker, Ocular

Cleared on Aug 29, 1994 after a 662-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 29, 1994
Review
662 days
Class
Class I
Product code
HMR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K925606Source: FDA 510(k) database · 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.

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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?

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.

How does its category compare?

All HMR devices

HMR Marker, Ocular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HMR

FDA has decided no HMR device since 2007.

Median 510(k) review, days · HMR

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

Recalls per year · HMR

6in 2010

2010: 6
2007high 6 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HMR

8in 2025

2016: 12025: 8
2007high 8 (2025) · low 0 (2007)2025

MAUDE reports naming product code HMR, 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
20070—00
20080—00
20090—00
20100—60
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—08
20260—0—

More from Chiron Vision Corp.

34 FDA decisions under this applicant name. See the company

  • K970727Mport Foldable Lens Placement SystemChiron Vision Corp. · 19971 recall
  • K972808Hansatome MicrokeratomeChiron Vision Corp. · 1997
  • K960414Synergist Power PackChiron Vision Corp. · 1996
  • K944993Iolab.Site CD Phacoemulsification ModuleChiron Vision Corp. · 1995
  • K944995Iolab/Site Peristaltic ModuleChiron Vision Corp. · 1995

Recent decisions in HMR

The HMR category page

  • K053475Optipoint Corneal Marker, Model VPT-Opt-450Refractec, Inc. · 2006
  • K872747Laser Centering DeviceInnomed Corp. · 1987
  • K863663Ophthalmic Surgical Ocular MarkersMyocure, Inc. · 1986
  • K861535Optical Markers/Fixation Ring/Cannu & Irriga CannuCooperVision, Inc. · 1986

https://510kreport.com/device/K925606 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925606: Optical Zone/Hexagonal/Astigmatism/Radial Markers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925606

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