Cleared Traditional

K875016 - BIOSURGE MODEL ILVC-1

K875016 is an FDA 510(k) clearance for BIOSURGE MODEL ILVC-1, manufactured by Biosurge, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K875016 · Biosurge, Inc. · Cardiovascular device
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Feb 1988
Decision
87d
Days
Class 1
Risk

K875016 is an FDA 510(k) clearance for the BIOSURGE MODEL ILVC-1. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Biosurge, Inc. (Rochester, US). The FDA issued a Cleared decision on February 29, 1988 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biosurge, Inc. devices

FDA 510(k) Submission Details - K875016

510(k) Number K875016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1987
Decision Date February 29, 1988
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 54
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K875016.
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