510(k) Report

510(k) · Cleared

Cleared

F.T.I. Medical Light Guide

K904378510(k) TraditionalCleared Jan 16, 1991114-day reviewClass I21 CFR 874.4350

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

Fiberoptics Technology, Inc. · EQH Source, Carrier, Fiberoptic Light

Cleared on Jan 16, 1991 after a 114-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jan 16, 1991
Review
114 days
Class
Class I
Product code
EQH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK904378 F.T.I. Medical Light GuideFiberoptics Technology, Inc. · 1991
  2. Descendant · cites it directly · 2 of its ownK082992 Axxion Light GuideSpinal Elements, Inc. · 2009
  3. Descendant · 2 generations on · 1 of its ownK101496 Cablecap Model: WLF, STZ, AcmSensormed · 2010
  4. Descendant · 3 generations on · 0 of its ownK113330 CablecapSensormed · 2012

Most influential descendants

Showing 3 of 3 · See all
  • K082992Axxion Light GuideSpinal Elements, Inc. · 2009 · cites it directly2descendants
  • K101496Cablecap Model: WLF, STZ, AcmSensormed · 2010 · 2 generations on1descendant
  • K113330CablecapSensormed · 2012 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904378F.T.I. Medical Light GuideFiberoptics Technology, Inc.1991—
+1K082992Axxion Light GuideSpinal Elements, Inc.2009—
+2K101496Cablecap Model: WLF, STZ, AcmSensormed2010—
+3K113330CablecapSensormed2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201210
FIG. 1 — Lineage of K904378, 1991–2012Source: 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 EQH? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K082992Axxion Light GuideSpinal Elements, Inc.20092

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, K082992 (Spinal Elements, Inc., 2009) has gone furthest, with 2 descendants of its own.

How does its category compare?

All EQH devices

EQH Source, Carrier, Fiberoptic Light: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EQH

FDA has decided no EQH device since 2007.

Median 510(k) review, days · EQH

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

Recalls per year · EQH

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · EQH

2in 2024

2008: 22009: 22010: 22011: 12012: 22013: 22014: 12015: 12016: 22017: 32019: 12021: 12022: 12024: 2
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code EQH, 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—10
20080—02
20090—02
20100—02
20110—01
20120—02
20130—02
20140—01
20150—01
20160—02
20170—03
20180—00
20190—01
20200—00
20210—01
20220—01
20230—00
20240—02
20250—00
20260—0—

More from Fiberoptics Technology, Inc.

2 FDA decisions under this applicant name. See the company

  • K102167LO-50 Led Light SourceFiberoptics Technology, Inc. · 2010

Recent decisions in EQH

The EQH category page

  • K945876Weco Endoscopic System with Fiber Optic LightWells Johnson Co. · 1995
  • K954184Jed-Light Fiberoptic Light SourceJedmed Instrument Co. · 1995
  • K951829Cold Light Source Los 150Laser-Optik-Systeme GmbH & Co. KG · 1995
  • K932771Battery Powered, Disposable Endoscope Light SourceXomed-Treace, Inc. · 1994
  • K941661GM Opti*Cam Camer with Dental Fiber Optic LightGm Engineering, Inc. · 1994

https://510kreport.com/device/K904378 · printed Nov 5, 2026

Cite this page

510(k) Report. “K904378: F.T.I. Medical Light Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904378

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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