510(k) Report

510(k) · Cleared

Cleared

Metal Halide Light Source, Models MV-9088-T, MV-9088

K012265510(k) TraditionalCleared Oct 17, 200190-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

Circon Video · FCW Light Source, Fiberoptic, Routine

Cleared on Oct 17, 2001 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 107 later devices descend from it.

Decided
Oct 17, 2001
Review
90 days
Class
Class II
Product code
FCW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2016: 3 descendants cleared2015: 2 descendants cleared2011: 1 descendant cleared2013: 1 descendant cleared2014: 2 descendants cleared2017: 3 descendants cleared2018: 4 descendants cleared2021: 9 descendants cleared2019: 3 descendants cleared2022: 11 descendants cleared2024: 13 descendants cleared2020: 7 descendants cleared2023: 14 descendants cleared2026: 18 descendants cleared2025: 15 descendants cleared200020052010201520202025
  1. This deviceK012265 Metal Halide Light Source, Models MV-9088-T, MV-9088Circon Video · 2001
  2. Descendant · cites it directly · 106 of its ownK091515 Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · Recalled
  3. Descendant · 2 generations on · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
  4. Descendant · 3 generations on · 103 of its ownK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
  5. Descendant · 3 generations on · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
  6. Descendant · 4 generations on · 76 of its ownK142310 Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014

Showing 5 of 107 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12013: 12014: 22015: 22016: 32017: 32018: 42019: 32020: 72021: 92022: 112023: 142024: 132025: 152026: 18
2009high 18 (2026) · low 0 (2010)2026

Most influential descendants

Showing 5 of 107 · See all
  • K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc. · 2009 · cites it directly106descendants
  • K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · 2 generations on104descendants
  • K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013 · 3 generations on103descendants
  • K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · 3 generations on87descendants
  • K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy · 2014 · 4 generations on76descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012265Metal Halide Light Source, Models MV-9088-T, MV-9088Circon Video2001—
+1K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc.20091
+2K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20112
+3K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013—
+3K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20142
+4K142310Stryker Infrared Fluorescence (IRF) Imaging SystemStryker Endoscopy2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201310
201420
201520
201630
201730
201840
201930
202070
202190
2022110
2023140
2024130
2025150
2026180
FIG. 1 — Lineage of K012265, 2001–2026Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FCW? 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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (107)

See all 107

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

NumberDeviceApplicantDecidedDescendants
K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc.2009106

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, K091515 (Novadaq Technologies, Inc., 2009) has gone furthest, with 106 descendants of its own.

How does its category compare?

All FCW devices

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

FDA decisions per year · FCW

1in 2014

2008: 22009: 12010: 12012: 22013: 12014: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FCW

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

Recalls per year · FCW

4in 2011

2011: 4
2007high 4 (2011) · low 0 (2007)2026

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

Adverse event reports per year · FCW

140in 2025

2007: 32008: 22009: 1482010: 7132011: 6032012: 772013: 292014: 112015: 242016: 292017: 592018: 762019: 1182020: 1522021: 1472022: 1662023: 1792024: 1792025: 140
2007high 713 (2010) · low 2 (2008)2025

MAUDE reports naming product code FCW, 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—03
20082—02
20091—0148
20101—0713
20110—4603
20122—077
20131—029
20141—011
20150—024
20160—029
20170—059
20180—076
20190—0118
20200—0152
20210—0147
20220—0166
20230—0179
20240—0179
20250—0140
20260—0—

What is it indicated for?

The intended use for the Metal Halide Light Sources is to provide optimized light for viewing procedures carried out with flexible and rigid endoscopes.

These devices are marketed as reusable devices and the methods for cleaning the devices are included in Section 5, “STERILITY INFORMATION”.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Circon Video

14 FDA decisions under this applicant name. See the company

  • K012758Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models MR-9, MR-9L,Circon Video · 2002
  • K011876Dolphin II Fluid Management System, Model Dol-2Circon Video · 2002
  • K011849Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series…Circon Video · 2001
  • K012929Flexible Pediatric Cystoureteroscope, Model Aur- 735Circon Video · 2001
  • K012951Apn-2 Usa Series Flexible CholedochoscopeCircon Video · 2001

Recent decisions in FCW

The FCW category page

  • K131226Novaprobe Led Light SourceNovaprobe Incorporated · 2014
  • K123956Power Led 175KARL STORZ Endoscopy-America, Inc. · 2013
  • K123359OVS1 Video SystemOlive Medical Corp. · 2012
  • K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
  • K093792Led Light SourceSunoptic Technologies, LLC · 2010

https://510kreport.com/device/K012265 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012265: Metal Halide Light Source, Models MV-9088-T, MV-9088.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012265

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026