Cleared Traditional

K101158 - LIC INSTRUMENT PROCESSING SYSTEM

K101158 is an FDA 510(k) clearance for LIC INSTRUMENT PROCESSING SYSTEM, manufactured by Langford IC Systems, Inc.. The device is a Class 2 General Hospital device with product code FEB cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K101158 · Langford IC Systems, Inc. · General Hospital
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May 2011
Decision
375d
Days
Class 2
Risk

K101158 is an FDA 510(k) clearance for the LIC INSTRUMENT PROCESSING SYSTEM. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Langford IC Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on May 6, 2011 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Langford IC Systems, Inc. devices

FDA 510(k) Submission Details - K101158

510(k) Number K101158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2010
Decision Date May 06, 2011
Days to Decision 375 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 129d · This submission: 375d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEB Device Classification - Class 2, Special Controls

Product Code FEB Accessories, Cleaning, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General Hospital devices follow this clearance model.

Regulatory Peers - FEB Accessories, Cleaning, For Endoscope

All 33
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K101158.
Acu-sInQ Complete Endoscope Cleaning Aid System
K181865 · STERIS Corporation · Dec 2018
EVOTECH ECR
K140977 · Advanced Sterilization Products · Dec 2014
ENDOSCOPE REPROCESSOR OER-MINI
K120357 · Olympus Medical Systems Corp. · Dec 2012
ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO
K103264 · Olympus Medical Systems Corporation · Feb 2011
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
K092387 · Minntech Corp. · Apr 2010
ENDOSCOPE REPROCESSOR OER-PRO
K093106 · Olympus Medical Systems Corporation · Feb 2010