Cleared Traditional

K934699 - RESPIRONICS BAGEASY ENCOR ADULT SEMI-RE...

K934699 is an FDA 510(k) clearance for RESPIRONICS BAGEASY ENCOR ADULT SEMI-RE..., manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 462-day FDA review.

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

FDA 510(k) Submission Details - K934699

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
322d slower than avg
Panel avg: 140d · This submission: 462d
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 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K934699.
AMBU SPUR NEONATE
K964584 · Ambu, Inc. · May 1997
DMR/CO2 COMBO KTI
K960468 · Nellcor Puritan Bennett, Inc. · Apr 1996
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
K952169 · Intertech Resources, Inc. · Jun 1995
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