Cleared Traditional

VIRAPUMP II (MODELS AND MODEL M) (K961607) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961607 · Viatro, Corp. · General Hospital
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Dec 1996
Decision
225d
Days
Class 2
Risk

K961607 is an FDA 510(k) clearance for the VIRAPUMP II (MODELS AND MODEL M). Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Viatro, Corp. (Cleveland, US). The FDA issued a Cleared decision on December 6, 1996 after a review of 225 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.

View all Viatro, Corp. devices

Submission Details

510(k) Number K961607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1996
Decision Date December 06, 1996
Days to Decision 225 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 129d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K961607.
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
K181472 · Advanced Sterilization Products (Asp) · Apr 2019
Acu-sInQ Complete Endoscope Cleaning Aid System
K181865 · STERIS Corporation · Dec 2018
RIWO SYSTEM TRAYS
K012309 · Richard Wolf Medical Instruments Corp. · Oct 2001
EW-10 AND EW-20
K915402 · Olympus Corp. · Jun 1995
AUTO SUTURE* ANTI-FOG DEVICE**
K944249 · United States Surgical, A Division of Tyco Healthc · Sep 1994