510(k) Report

510(k) · Cleared

Cleared

Microendoscope Model S-0001 Single Light Source, Microendoscope, Model D-0001 Dual Light Source Sterile

K092739510(k) TraditionalCleared Jan 12, 2010126-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

C-Link Micro Imaging, Inc. · ODF Mini Endoscope, Gastroenterology-Urology

Cleared on Jan 12, 2010 as substantially equivalent to K011189 (Acueity, Inc., 2001) after a 126-day review. Its family tree reaches back 1 generation to 2001.

Decided
Jan 12, 2010
Review
126 days
Class
Class II
Product code
ODF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011189 (2001). No later device cites it as a predicate yet.

K011189 · Viaduct Microendoscope and Accessories · Acueity, Inc. · 20012000200220042006200820102012
K011189 · Viaduct Microendoscope and Accessories · Acueity, Inc. · 20010
  1. Root · 1 generation backK011189 Viaduct Microendoscope and AccessoriesAcueity, Inc. · 2001
  2. This deviceK092739 Microendoscope Model S-0001 Single Light Source, Microendoscope…C-Link Micro Imaging, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011189Viaduct Microendoscope and AccessoriesAcueity, Inc.2001—
0 (this device)K092739Microendoscope Model S-0001 Single Light Source, Microendoscope, Model D-0001…C-Link Micro Imaging, Inc.2010—
FIG. 1 — Lineage of K092739, 2001–2010Source: 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ODF? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K011189Viaduct Microendoscope and AccessoriesAcueity, Inc.2001—

Also cleared against K011189: 5 other devices →

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.

What does this lineage say?

  • Its one ancestor has no recall.
  • 5 other devices also cite its predicate K011189.

How does its category compare?

All ODF devices

ODF Mini Endoscope, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · ODF

1in 2010

2009: 22010: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODF

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

Recalls per year · ODF

No recall names ODF since 2007.

Adverse event reports per year · ODF

1in 2022

2008: 52009: 42010: 12011: 52012: 42013: 32014: 22015: 12016: 12017: 12022: 1
2007high 5 (2008) · low 0 (2007)2025

MAUDE reports naming product code ODF, 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—05
20092—04
20101—01
20110—05
20120—04
20130—03
20140—02
20150—01
20160—01
20170—01
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.

Indications for use as stated in the FDA summary.

Also cleared against K011189

5 other devices cite the same predicate.

  • K063078MicroendoscopeAcclarent, Inc. · 2006
  • K051073Midiview Series of MicroendoscopesMillennium Devices, Inc. · 2006
  • K050650Novacyte Microendoscope and Accessories, Models NC1000;NCAM1000Cytyc Surgical Products · 2005
  • K040949Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
  • K020310Davlite Microendoscope & AccessoriesDavlite Technologies · 2002

Recent decisions in ODF

The ODF category page

  • K091962Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model LS-200Lumenis, Inc. · 2009
  • K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
  • K052194Spyglass Direct Visualization Probe and OcularBoston Scientific Corp · 20052 recalls
  • K050403Spyglass Direct Visulation ProbeBoston Scientific Corp · 2005
  • K9633545 Star Medical EndoscopeFive Star Medical, Inc. · 1997

https://510kreport.com/device/K092739 · printed Nov 5, 2026

Cite this page

510(k) Report. “K092739: Microendoscope Model S-0001 Single Light Source, Microendoscope, Model D-0001 Dual Light Source Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092739

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026