510(k) Report

510(k) · Cleared

Cleared

Model 5135 Auto LP/Flash

K944607510(k) TraditionalCleared Dec 13, 199485-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

Richard Wolf Medical Instruments Corp. · GCT Light Source, Endoscope, Xenon Arc

Cleared on Dec 13, 1994 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Dec 13, 1994
Review
85 days
Class
Class II
Product code
GCT
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared1990200020102020
  1. This deviceK944607 Model 5135 Auto LP/FlashRichard Wolf Medical Instruments Corp. · 1994
  2. Descendant · cites it directly · 1 of its ownK981804 Xenon Light Source Model LS6000Contec Medical Vision, Ltd. · 1998
  3. Descendant · cites it directly · 0 of its ownK982962 Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K981804Xenon Light Source Model LS6000Contec Medical Vision, Ltd. · 1998 · cites it directly1descendant
  • K982962Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944607Model 5135 Auto LP/FlashRichard Wolf Medical Instruments Corp.1994—
+1K981804Xenon Light Source Model LS6000Contec Medical Vision, Ltd.1998—
+1K982962Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
FIG. 1 — Lineage of K944607, 1994–1998Source: 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.

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  • 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? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981804Xenon Light Source Model LS6000Contec Medical Vision, Ltd.19981
K982962Xenon Light Source, Models LS6180, LS6035Contec Medical Vision, Ltd.19980

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, K981804 (Contec Medical Vision, Ltd., 1998) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GCT devices

GCT Light Source, Endoscope, Xenon Arc: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCT

1in 2010

2007: 12008: 12010: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCT

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

Recalls per year · GCT

No recall names GCT since 2007.

Adverse event reports per year · GCT

347in 2025

2007: 322008: 292009: 1532010: 212011: 1322012: 362013: 72014: 112015: 82016: 152017: 142018: 202019: 182020: 1142021: 1492022: 1582023: 2002024: 2962025: 347
2007high 347 (2025) · low 7 (2013)2025

MAUDE reports naming product code GCT, 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
20071—032
20081—029
20090—0153
20101—021
20110—0132
20120—036
20130—07
20140—011
20150—08
20160—015
20170—014
20180—020
20190—018
20200—0114
20210—0149
20220—0158
20230—0200
20240—0296
20250—0347
20260—0—

More from Richard Wolf Medical Instruments Corp.

146 FDA decisions under this applicant name. See the company

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  • K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
  • K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
  • K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar…Richard Wolf Medical Instruments Corp. · 2012

Recent decisions in GCT

The GCT category page

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https://510kreport.com/device/K944607 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944607: Model 5135 Auto LP/Flash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944607

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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