Cleared Traditional

K952880 - MODEL LP-1000 VOLUME VENTILATOR

K952880 is an FDA 510(k) clearance for MODEL LP-1000 VOLUME VENTILATOR, manufactured by Aequitron Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K952880 · Aequitron Medical, Inc. · Anesthesiology device
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Jun 1996
Decision
364d
Days
Class 2
Risk

K952880 is an FDA 510(k) clearance for the MODEL LP-1000 VOLUME VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 20, 1996 after a review of 364 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 Aequitron Medical, Inc. devices

FDA 510(k) Submission Details - K952880

510(k) Number K952880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 22, 1995
Decision Date June 20, 1996
Days to Decision 364 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
224d slower than avg
Panel avg: 140d · This submission: 364d
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 326
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K952880.
OHMEDA 7900 ANESTHESIA VENTILATOR
K960964 · Ohmeda Medical · Sep 1996
DRAGER MICRO VENT
K953238 · Drager, Inc. · Sep 1996
BEAR CUB INFANT PRESSURE VENTILATOR
K955865 · Allied Healthcare Products, Inc. · Aug 1996
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
K950484 · Bird Products Corp. · May 1996
NARKOMED AV2+ ANESTHESIA VENTILATOR
K953228 · Draeger Medical, Inc. · Mar 1996
ADULT VENTILATOR
K943106 · Infrasonics Corp. · Dec 1995