510(k) Report

510(k) · Cleared

Cleared

Modified Series 2100 Endoscopes

K912089510(k) TraditionalCleared Aug 12, 199191-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

Medical Laser, Inc. · ODF Mini Endoscope, Gastroenterology-Urology

Cleared on Aug 12, 1991 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.

Decided
Aug 12, 1991
Review
91 days
Class
Class II
Product code
ODF
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1999: 2 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared1990200020102020
  1. This deviceK912089 Modified Series 2100 EndoscopesMedical Laser, Inc. · 1991
  2. Descendant · cites it directly · 4 of its ownK962255 Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc. · 1996
  3. Descendant · 2 generations on · 2 of its ownK991377 Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999
  4. Descendant · 2 generations on · 0 of its ownK082038 Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC · 2009
  5. Descendant · 3 generations on · 0 of its ownK080780 Anchorage Scope, Model 000003Epitek, Inc. · 2008
  6. Descendant · 3 generations on · 0 of its ownK993445 Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999

Most influential descendants

Showing 5 of 5 · See all
  • K962255Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc. · 1996 · cites it directly4descendants
  • K991377Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies · 1999 · 2 generations on2descendants
  • K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC · 2009 · 2 generations on0descendants
  • K080780Anchorage Scope, Model 000003Epitek, Inc. · 2008 · 3 generations on0descendants
  • K993445Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies · 1999 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912089Modified Series 2100 EndoscopesMedical Laser, Inc.1991—
+1K962255Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc.1996—
+2K991377Omnisonics Flexible Fiber Optic Endoscope and CouplerOmnisonics Medical Technologies1999—
+2K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC2009—
+3K080780Anchorage Scope, Model 000003Epitek, Inc.2008—
+3K993445Omnisonic Endoscopic DeflectorOmnisonics Medical Technologies1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199920
200810
200910
FIG. 1 — Lineage of K912089, 1991–2009Source: 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 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K962255Clarus Murphypen Endoscope (2127-XXX)Clarus Medical Systems, Inc.19964

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, K962255 (Clarus Medical Systems, Inc., 1996) has gone furthest, with 4 descendants of its own.

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.

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—

More from Medical Laser, Inc.

11 FDA decisions under this applicant name. See the company

  • K913136Laser Endoscope Disc Decompression KitsMedical Laser, Inc. · 1991
  • K912265Medilase Semi-Rigid Instrod Sheath Series AE1000Medical Laser, Inc. · 1991
  • K912447Series 5000 Endoscope Console Models 5100 and 5200Medical Laser, Inc. · 1991
  • K901464Medilase Series 2200 EndoscopeMedical Laser, Inc. · 1990
  • K900894Medilase Series 2100 EndoscopeMedical Laser, Inc. · 1990

Recent decisions in ODF

The ODF category page

  • K092739Microendoscope Model S-0001 Single Light Source, Microendoscope, Model D-0001 Dual Light Source SterileC-Link Micro Imaging, Inc. · 2010
  • 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

https://510kreport.com/device/K912089 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912089: Modified Series 2100 Endoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912089

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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