510(k) Report

510(k) · Cleared

Cleared

Angiolaz Video Endoscopic System Model CAMLUM1 and Accessories

K933868510(k) TraditionalCleared Nov 10, 199396-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

Angiolaz, Inc. · GCT Light Source, Endoscope, Xenon Arc

Cleared on Nov 10, 1993 after a 96-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 10, 1993
Review
96 days
Class
Class II
Product code
GCT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK933868 Angiolaz Video Endoscopic System Model CAMLUM1 and AccessoriesAngiolaz, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK053412 Flexiscope, Models 50MH and 50 MHCSchoelly Imaging, Inc. · 2006
  3. Descendant · 2 generations on · 0 of its ownK090601 FSC 2Schoelly Imaging, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K053412Flexiscope, Models 50MH and 50 MHCSchoelly Imaging, Inc. · 2006 · cites it directly1descendant
  • K090601FSC 2Schoelly Imaging, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933868Angiolaz Video Endoscopic System Model CAMLUM1 and AccessoriesAngiolaz, Inc.1993—
+1K053412Flexiscope, Models 50MH and 50 MHCSchoelly Imaging, Inc.2006—
+2K090601FSC 2Schoelly Imaging, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
FIG. 1 — Lineage of K933868, 1993–2009Source: 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 GCT? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K053412Flexiscope, Models 50MH and 50 MHCSchoelly Imaging, Inc.20061

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, K053412 (Schoelly Imaging, Inc., 2006) 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 Angiolaz, Inc.

10 FDA decisions under this applicant name. See the company

  • K994362Headlamp HL2000.Angiolaz, Inc. · 2000
  • K99244750 W Metal Halide Illuminator, Ves 0501.Angiolaz, Inc. · 1999
  • K982397Ves 3001-M Complete Video Endoscopic SystemAngiolaz, Inc. · 1998
  • K982409VES 1501-MAngiolaz, Inc. · 1998
  • K981819Angiolaz Ves-1CAMAngiolaz, Inc. · 1998

Recent decisions in GCT

The GCT category page

  • K093125Alphaxenon Light 180 W and 300 WGimmi GmbH · 2010
  • K082925Xenon-100 SCB Light Source, Model 20132620KARL STORZ Endoscopy-America, Inc. · 2008
  • K070376Conmed Linvatec 300W Xenon Light SourceConmed Linvatec · 20072 recalls
  • K040949Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
  • K022490Ksea Medi PackKARL STORZ Endoscopy-America, Inc. · 2003

https://510kreport.com/device/K933868 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933868: Angiolaz Video Endoscopic System Model CAMLUM1 and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933868

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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