Cleared Traditional

K993194 - RUSCH MANUAL RESUSCITATOR BAG

K993194 is an FDA 510(k) clearance for RUSCH MANUAL RESUSCITATOR BAG, manufactured by Rusch, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K993194 · Rusch, Inc. · Anesthesiology device
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Mar 2000
Decision
183d
Days
Class 2
Risk

K993194 is an FDA 510(k) clearance for the RUSCH MANUAL RESUSCITATOR BAG. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Rusch, Inc. (Duluth, US). The FDA issued a Cleared decision on March 24, 2000 after a review of 183 days - an extended review 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: 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 Rusch, Inc. devices

FDA 510(k) Submission Details - K993194

510(k) Number K993194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1999
Decision Date March 24, 2000
Days to Decision 183 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
43d slower than avg
Panel avg: 140d · This submission: 183d
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 K993194.
NELLCOR INDGO MANUAL RESUSCITATOR
K023494 · Nellcor Puritan Bennett, Inc. · Feb 2003
PMX DISPOSABLE BAG MASK RESUSCITATOR
K014071 · Allied Healthcare Products, Inc. · Oct 2002
AMBU NEONATE SILICONE RESUSCITATOR
K993278 · Ambu, Inc. · May 2000
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
K973419 · Nellcor Puritan Bennett, Inc. · Mar 1998
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
K973106 · Allied Healthcare Products, Inc. · Jan 1998
OHMEDA INFANT RESUSCITATION SYSTEM
K971243 · Ohmeda Medical · Dec 1997