Cleared Traditional

BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR (K934310) - FDA 510(k) Clearance

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

K934310 · Respironics, Inc. · Anesthesiology device
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Dec 1993
Decision
104d
Days
Class 2
Risk

K934310 is an FDA 510(k) clearance for the BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR. 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 December 14, 1993 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Respironics, Inc. devices

Submission Details

510(k) Number K934310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1993
Decision Date December 14, 1993
Days to Decision 104 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
36d faster than avg
Panel avg: 140d · This submission: 104d
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 13
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K934310.
OHMEDA INFANT RESUSCITATION SYSTEM
K971243 · Ohmeda Medical · Dec 1997
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K934699 · Respironics, Inc. · Jan 1995
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
K940581 · Respironics, Inc. · May 1994
RESPIRONICS INFANT BAGEASY
K895351 · Respironics, Inc. · Oct 1989
RESPIRONICS VENTEASY
K842693 · Respironics, Inc. · Aug 1984