Cleared Traditional

K941871 - LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100

K941871 is an FDA 510(k) clearance for LSPI AUTOMATIC VENTILATOR, 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 266-day FDA review.

K941871 · Life Support Products, Inc. · Anesthesiology device
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Jan 1995
Decision
266d
Days
Class 2
Risk

K941871 is an FDA 510(k) clearance for the LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Life Support Products, Inc. (Saint Louis, US). The FDA issued a Cleared decision on January 9, 1995 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Life Support Products, Inc. devices

FDA 510(k) Submission Details - K941871

510(k) Number K941871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1994
Decision Date January 09, 1995
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 140d · This submission: 266d
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 K941871.
PARAPAC
K960515 · Pneupac , Ltd. · Oct 1996
DRAGER MEDICAL AIR COMPRESSOR
K951126 · Drager, Inc. · Mar 1995
LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
K941870 · Life Support Products, Inc. · Jan 1995
IMPACT MODEL 753
K931473 · Impact Instrumentation, Inc. · Dec 1994
LSPI AUTOMATIC VENTILATOR, MODEL AV3000
K932199 · Life Support Products, Inc. · Nov 1993
LSPI AUTOMATIC VENTILATOR
K932200 · Life Support Products, Inc. · Nov 1993