Cleared Traditional

K831198 - CPR HEARTSAVER AND BREATHOLATOR

K831198 is the FDA 510(k) clearance for CPR HEARTSAVER AND BREATHOLATOR by Cervco Corp.. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K831198 · Cervco Corp. · Anesthesiology device

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Jun 1983

Decision

73d

Days

Class 2

Risk

K831198 is an FDA 510(k) clearance for the CPR HEARTSAVER AND BREATHOLATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Cervco Corp. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983 after a review of 73 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.

View all Cervco Corp. devices

Submission Details

510(k) Number	K831198 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 12, 1983
Decision Date	June 24, 1983
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

67d faster than avg

Panel avg: 140d · This submission: 73d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 33

Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K831198.

STAT BLUE DISPOS. MANUAL RESUSCITATOR

K850436 · Vital Signs, Inc. · Feb 1985

RESPIRONICS VENTEASY

K842693 · Respironics, Inc. · Aug 1984

CODE BLUE MANUAL RESUSCITATOR

K831885 · Vital Signs, Inc. · Sep 1983

RESUSCITATION CIRCUIT

K812273 · Vital Signs, Inc. · Aug 1981

PMR-2 PURITAN MANUAL RESUSCITATOR

K802813 · Puritan Bennett Corp. · Dec 1980

RESUSCI-BAG-VALVE

K791468 · Concept, Inc. · Aug 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K831198

Cervco Corp.

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Anesthesiology

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