Cleared Traditional

K140977 - EVOTECH ECR

K140977 is an FDA 510(k) clearance for EVOTECH ECR, manufactured by Advanced Sterilization Products. The device is a Class 2 General Hospital device with product code FEB cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K140977 · Advanced Sterilization Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
250d
Days
Class 2
Risk

K140977 is an FDA 510(k) clearance for the EVOTECH ECR. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on December 22, 2014 after a review of 250 days - an extended review cycle.

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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K140977

510(k) Number K140977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2014
Decision Date December 22, 2014
Days to Decision 250 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 129d · This submission: 250d
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 55
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K140977.
Scope-Assist Flushing Sink
K162120 · Custom Ultrasonics, Inc. · Apr 2017
Scope Buddy Plus Endoscope Flushing Aid
K162128 · Medivators, Inc. · Dec 2016
EVOTECH ECR
K152189 · Advanced Sterilization Products (Asp) · Jul 2016
SYSTEM 83 PLUS
K122172 · Custom Ultrasonics · Jan 2013
ENDOSCOPE REPROCESSOR OER-MINI
K120357 · Olympus Medical Systems Corp. · Dec 2012
LIC INSTRUMENT PROCESSING SYSTEM
K101158 · Langford IC Systems, Inc. · May 2011
K140977 · EVOTECH ECR
Download PDF FDA Summary Advanced Sterilizatio…