510(k) Report

510(k) · Cleared

Cleared

Ors Model 6000 Endoscope Holder

K051979510(k) SpecialCleared Aug 30, 200540-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

O.R. Solutions, Inc. · OCT Anti Fog Solution And Accessories, Endoscopy

Cleared on Aug 30, 2005 as substantially equivalent to K990334 (KARL STORZ Endoscopy-America, Inc., 1999) after a 40-day review. Its family tree reaches back 1 generation to 1999. 25 later devices descend from it.

Decided
Aug 30, 2005
Review
40 days
Class
Class II
Product code
OCT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K990334 (1999). 25 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2014: 1 descendant cleared2017: 2 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2018: 2 descendants cleared2022: 3 descendants cleared2010: 1 descendant cleared2016: 2 descendants cleared2026: 3 descendants cleared2025: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2019: 1 descendant cleared2020: 2 descendants clearedK990334 · Ksea Endoscope Holder · KARL STORZ Endoscopy-America, Inc. · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 7 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 2 descendants K990334 · Ksea Endoscope Holder · KARL STORZ Endoscopy-America, Inc. · 19990+5
  1. Root · 1 generation backK990334 Ksea Endoscope HolderKARL STORZ Endoscopy-America, Inc. · 1999
  2. This deviceK051979 Ors Model 6000 Endoscope HolderO.R. Solutions, Inc. · 2005
  3. Descendant · cites it directly · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
  4. Descendant · 2 generations on · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
  5. Descendant · 3 generations on · 8 of its ownK151117 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015
  6. Descendant · 4 generations on · 7 of its ownK160172 Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016
  7. Descendant · 5 generations on · 6 of its ownK170103 Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12010: 12014: 12015: 22016: 22017: 22018: 22019: 12020: 22022: 32023: 12024: 22025: 12026: 3
2006high 3 (2022) · low 0 (2007)2026

Most influential descendants

Showing 5 of 25 · See all
  • K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation · 2006 · cites it directly23descendants
  • K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · 2 generations on16descendants
  • K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2015 · 3 generations on8descendants
  • K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc. · 2016 · 4 generations on7descendants
  • K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc. · 2017 · 5 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K990334Ksea Endoscope HolderKARL STORZ Endoscopy-America, Inc.1999—
0 (this device)K051979Ors Model 6000 Endoscope HolderO.R. Solutions, Inc.2005—
+1K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens…New Wave Surgical Corporation20062
+2K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC2008—
+3K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.2015—
+4K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.2016—
+5K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201010
201410
201520
201620
201720
201820
201910
202020
202230
202310
202420
202510
202630
FIG. 1 — Lineage of K051979, 1999–2026Source: 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 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 OCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OCT device

  1. #1 K251068 KnoxFog Anti-fogging Devicescore 10.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*K990334Ksea Endoscope Holder
Summary page 1
…e Name: ORS 6000 Endoscope Holder 3. Classification Name: Warmer, Irrigation, Solution, Accessory 4. Predicate Devices: Karl Storz KSEA Endoscope Holder K990334 5. Description The ORS 6000 Endoscope Holder (figures 1) is designed to prevent fogging or wetting of the s…
KARL STORZ Endoscopy-America, Inc.1999—

Also cleared against K990334: 4 other devices →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation200623
K142173Non-Sterile Ors-400N Scope Pillow Warmer DrapeEcolab, Inc.20140

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.
  • Of its descendants, K062779 (New Wave Surgical Corporation, 2006) has gone furthest, with 23 descendants of its own.
  • 4 other devices also cite its predicate K990334.

How does its category compare?

All OCT devices

OCT Anti Fog Solution And Accessories, Endoscopy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCT

1in 2025

2007: 12008: 12010: 12011: 12012: 12016: 12017: 12019: 12020: 12022: 12024: 12025: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCT

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

Recalls per year · OCT

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · OCT

13in 2025

2015: 132016: 272017: 182018: 202019: 202020: 142021: 162022: 102023: 132024: 92025: 13
2007high 27 (2016) · low 0 (2007)2025

MAUDE reports naming product code OCT, 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—00
20081—00
20090—00
20101—00
20111—00
20121—00
20130—00
20140—00
20150—013
20161—027
20171—018
20180—020
20191—020
20201—014
20210—016
20221—110
20230—013
20241—09
20251—013
20260—0—

What is it indicated for?

The ORS 6000 Endoscope Holder is a single use disposable device as an accessory for ORS Solution Warmers. The ORS 6000 Endoscope Holder is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.

Indications for use as stated in the FDA summary.

Also cleared against K990334

4 other devices cite the same predicate.

  • K190576WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
  • K050051Armand Endoscope HolderKLS-Martin L.P. · 2005
  • K024251SightfixWorld of Medicine Lemke GmbH · 2003
  • K992006Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999

More from O.R. Solutions, Inc.

7 FDA decisions under this applicant name. See the company

  • K023282ORS-3000LDO.R. Solutions, Inc. · 20021 recall
  • K0232831075LD Hush-SlushO.R. Solutions, Inc. · 2002
  • K021288ORS-1000LDO.R. Solutions, Inc. · 20021 recall
  • K021289Warmer 2000LDO.R. Solutions, Inc. · 2002
  • K960836DMS-9000O.R. Solutions, Inc. · 1996

Recent decisions in OCT

The OCT category page

  • K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc. · 2025
  • K231822GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc. · 2024
  • K221293E-Brik Visualization AssistantJdi Surgical, Inc. · 2022
  • K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · 2020
  • K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd. · 2019

https://510kreport.com/device/K051979 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051979: Ors Model 6000 Endoscope Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051979

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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