Cleared Traditional

K934699 - RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE (FDA 510(k) Clearance)

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

K934699 · Respironics, Inc. · Anesthesiology device
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Jan 1995
Decision
462d
Days
Class 2
Risk

K934699 is an FDA 510(k) clearance for the RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 5, 1995 after a review of 462 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 Respironics, Inc. devices

Submission Details

510(k) Number K934699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1993
Decision Date January 05, 1995
Days to Decision 462 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
323d slower than avg
Panel avg: 139d · This submission: 462d
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 208
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