Cleared Traditional

K871147 - MODIFIED CPREVIVER

K871147 is an FDA 510(k) clearance for MODIFIED CPREVIVER, manufactured by Augerscope, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K871147 · Augerscope, Inc. · Anesthesiology device
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Apr 1987
Decision
39d
Days
Class 2
Risk

K871147 is an FDA 510(k) clearance for the MODIFIED CPREVIVER. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Augerscope, Inc. (Sylmar, US). The FDA issued a Cleared decision on April 20, 1987 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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.

FDA 510(k) Submission Details - K871147

510(k) Number K871147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1987
Decision Date April 20, 1987
Days to Decision 39 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 140d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 164
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K871147.
NONREBREATHING CIRCUIT
K882285 · Dryden Corp. · Aug 1988
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
K874418 · Life Support Products, Inc. · Jan 1988
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
K873286 · Hospitak, Inc. · Oct 1987
PULMANEX TM (MODIFICATION)
K863026 · Life Design Systems, Inc. · Aug 1986
PULMANEX (TM)
K860693 · Life Design Systems, Inc. · Mar 1986
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
K860180 · Life Support Products, Inc. · Mar 1986
K871147 · MODIFIED CPREVIVER
Download PDF Augerscope, Inc.