510(k) Report

510(k) · Cleared

Cleared

GM Opti*Cam Camera with Fiber Optic Light

K941660510(k) TraditionalCleared May 24, 199449-day reviewClass II21 CFR 876.1500

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

Gm Engineering, Inc. · KYH Endoscope, Ophthalmic

Cleared on May 24, 1994 after a 49-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 24, 1994
Review
49 days
Class
Class II
Product code
KYH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K941660Source: 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.

Planning a device in KYH? 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 lists a 510(k) statement for it but has not posted the file, 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 KYH devices

KYH Endoscope, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYH

FDA has decided no KYH device since 2007.

Median 510(k) review, days · KYH

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

Recalls per year · KYH

No recall names KYH since 2007.

Adverse event reports per year · KYH

2in 2024

2024: 2
2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code KYH, 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—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—02
20250—00
20260—0—

More from Gm Engineering, Inc.

11 FDA decisions under this applicant name. See the company

  • K953348Articulating Retractor Tissue RetractorsGm Engineering, Inc. · 1995
  • K942626Continuous Flow Biopsy ProbeGm Engineering, Inc. · 1995
  • K932394Bernstein (TM) Uterine ManipulatorGm Engineering, Inc. · 1995
  • K941661GM Opti*Cam Camer with Dental Fiber Optic LightGm Engineering, Inc. · 1994
  • K942703GM Reusable and Disposable Trocar and GM Reusable and Disposable Ultra-Light CannulaGm Engineering, Inc. · 1994

https://510kreport.com/device/K941660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941660: GM Opti*Cam Camera with Fiber Optic Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941660

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