Cleared Traditional

K874656 - AUTOMATIC VENTILATOR AV2000

K874656 is an FDA 510(k) clearance for AUTOMATIC VENTILATOR AV2000, manufactured by Life Support Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K874656 · Life Support Products, Inc. · Anesthesiology device
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Jan 1988
Decision
61d
Days
Class 2
Risk

K874656 is an FDA 510(k) clearance for the AUTOMATIC VENTILATOR AV2000. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Life Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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: 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 Life Support Products, Inc. devices

FDA 510(k) Submission Details - K874656

510(k) Number K874656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date January 19, 1988
Days to Decision 61 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
79d faster than avg
Panel avg: 140d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 49
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K874656.
BIVONA CARDEN INTERMITTENT JETTING DEVICE
K895946 · Bivona Medical Technologies · Jan 1990
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
K892885 · Fisher & Paykel Electronics , Ltd. · Oct 1989
LSP AUTOMATIC VENTILATOR, MODEL 456
K870424 · Life Support Products, Inc. · Jan 1988
PATIENT VALVE WITH AIR ENTRAINMENT
K863410 · Pneupac , Ltd. · Jan 1987
MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR
K862830 · Pneupac , Ltd. · Oct 1986
IMPACT MODELS 701, 702 AND 703
K861272 · Impact Instrumentation, Inc. · May 1986