Cleared Special

ORS MODEL 6000 ENDOSCOPE HOLDER (K051979) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051979 · O.R. Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
40d
Days
Class 2
Risk

K051979 is an FDA 510(k) clearance for the ORS MODEL 6000 ENDOSCOPE HOLDER. Classified as Anti Fog Solution And Accessories, Endoscopy (product code OCT), Class II - Special Controls.

Submitted by O.R. Solutions, Inc. (Crofton, US). The FDA issued a Cleared decision on August 30, 2005 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all O.R. Solutions, Inc. devices

Submission Details

510(k) Number K051979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2005
Decision Date August 30, 2005
Days to Decision 40 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 130d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OCT Anti Fog Solution And Accessories, Endoscopy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCT Anti Fog Solution And Accessories, Endoscopy

All 26
Devices cleared under the same product code (OCT) and FDA review panel - the closest regulatory comparables to K051979.
KnoxFog Anti-fogging Device
K251068 · Uv One Hygienics, Inc. · Aug 2025
GOLFF Sterile Anti-Fog Solution
K231822 · Batrik Medical Manufacturing, Inc. · Feb 2024
E-Brik Visualization Assistant
K221293 · Jdi Surgical, Inc. · Jul 2022
Konix Anti-Fog Solution
K190864 · Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · Aug 2020
AMD Anti-Fog Solution
K181887 · Advanced Medical Design Co., Ltd. · Jan 2019
Medline Anti-Fog Solution
K152948 · Medline Industries, Inc. · Feb 2016