Cleared Traditional

K993528 - RUSCH EMERGENCY MASK

K993528 is an FDA 510(k) clearance for RUSCH EMERGENCY MASK, manufactured by Rusch, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K993528 · Rusch, Inc. · Anesthesiology device
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May 2000
Decision
226d
Days
Class 2
Risk

K993528 is an FDA 510(k) clearance for the RUSCH EMERGENCY MASK. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Rusch, Inc. (Duluth, US). The FDA issued a Cleared decision on May 31, 2000 after a review of 226 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 - K993528

510(k) Number K993528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1999
Decision Date May 31, 2000
Days to Decision 226 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
86d slower than avg
Panel avg: 140d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 71
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K993528.
HI-OX
K020665 · Sensor Medics Corp. · Jul 2002
Y2000 POCKET RESCUE
K010191 · Cheen Houng Ent. Co. , Ltd. · Mar 2001
RESUSCI INFLATE-A-SHIELD CPR BARRIER
K001742 · Laerdal Medical Corp. · Oct 2000
FACE-2-FACE CPR PROTECTION SHIELD
K991617 · Whiteline Plastics, Inc. · Nov 1999
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
K983631 · Instrumentation Industries, Inc. · Jul 1999
EMS MOUTH TO MASK RESUSCITATORS
K983919 · Engineered Medical Systems · Apr 1999