Cleared Traditional

K961607 - VIRAPUMP II (MODELS AND MODEL M)

K961607 is an FDA 510(k) clearance for VIRAPUMP II (MODELS AND MODEL M), manufactured by Viatro, Corp.. The device is a Class 2 General Hospital device with product code FEB cleared through the Traditional 510(k) pathway after a 225-day FDA review.

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

FDA 510(k) Submission Details - K961607

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
Combination Product No
PCCP Authorized No
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.

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 38
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K961607.
RIWO SYSTEM TRAYS
K012309 · Richard Wolf Medical Instruments Corp. · Oct 2001
VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
K973558 · Ultracell Medical Technologies, Inc. · Nov 1997
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
K964871 · Biosearch Medical Products, Inc. · Mar 1997
MILL-ROSE RIGID SCOPE CLEANING BRUSHES
K954745 · Mill-Rose Laboratory · Nov 1995
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