Cleared Traditional

K913474 - RESPIRE DISPOSABLE PULMONARY RESUSCITATOR

K913474 is the FDA 510(k) clearance for RESPIRE DISPOSABLE PULMONARY RESUSCITATOR by Med-Tek Innovations, Inc.. It is a Class 2 Anesthesiology device (product code BTM) cleared through the Traditional 510(k) pathway after a 548-day FDA review.

K913474 · Med-Tek Innovations, Inc. · Anesthesiology device
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Feb 1993
Decision
548d
Days
Class 2
Risk

K913474 is an FDA 510(k) clearance for the RESPIRE DISPOSABLE PULMONARY RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Med-Tek Innovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 3, 1993 after a review of 548 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Med-Tek Innovations, Inc. devices

Submission Details

510(k) Number K913474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1991
Decision Date February 03, 1993
Days to Decision 548 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
408d slower than avg
Panel avg: 140d · This submission: 548d
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 K913474.
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
K944347 · Puritan Bennett Corp. · Dec 1994
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K940581 · Respironics, Inc. · May 1994
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
K934310 · Respironics, Inc. · Dec 1993
MODIFICATION PURITAN-BENNETT INFANT PM2
K922004 · Puritan Bennett Corp. · May 1992
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
K920570 · Puritan Bennett Corp. · Feb 1992
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K913370 · Puritan Bennett Corp. · Aug 1991