Cleared Traditional

K870861 - UNI-VENT(TM) IMPACT MINUTE VOLUME VENTI...

K870861 is an FDA 510(k) clearance for UNI-VENT(TM) IMPACT MINUTE VOLUME VENTI..., manufactured by Impact Instrumentation, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K870861 · Impact Instrumentation, Inc. · Anesthesiology device
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Jan 1988
Decision
322d
Days
Class 2
Risk

K870861 is an FDA 510(k) clearance for the UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Impact Instrumentation, Inc. devices

FDA 510(k) Submission Details - K870861

510(k) Number K870861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date January 19, 1988
Days to Decision 322 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 140d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K870861.
6400ST INTERFACE MODULE-RS232
K880721 · Bird Products Corp. · Apr 1988
GAMBRO-ENGSTROM ERICA IV RESPIRATOR
K872482 · Gambro, Inc. · Mar 1988
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
K873215 · Puritan Bennett Corp. · Jan 1988
PRESSURE LIMIT CONTROL
K874415 · Draeger Medical, Inc. · Jan 1988
ASCENDING VENTILATOR BELLOWS
K874371 · Draeger Medical, Inc. · Dec 1987
PEDIATRIC BELLOWS
K873549 · Draeger Medical, Inc. · Oct 1987