Cleared Traditional

K870424 - LSP AUTOMATIC VENTILATOR, MODEL 456 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870424 · Life Support Products, Inc. · Anesthesiology device
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Jan 1988
Decision
353d
Days
Class 2
Risk

K870424 is an FDA 510(k) clearance for the LSP AUTOMATIC VENTILATOR, MODEL 456. 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 22, 1988 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Life Support Products, Inc. devices

Submission Details

510(k) Number K870424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date January 22, 1988
Days to Decision 353 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 139d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.