Cleared Traditional

K882604 - PULMO-PATTY

K882604 is an FDA 510(k) clearance for PULMO-PATTY, manufactured by Tower Stopper, Inc.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K882604 · Tower Stopper, Inc. · Anesthesiology device
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Jan 1989
Decision
194d
Days
Class 2
Risk

K882604 is an FDA 510(k) clearance for the PULMO-PATTY. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Tower Stopper, Inc. (Hancock, US). The FDA issued a Cleared decision on January 4, 1989 after a review of 194 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5665 - 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.

FDA 510(k) Submission Details - K882604

510(k) Number K882604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1988
Decision Date January 04, 1989
Days to Decision 194 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 140d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYI Device Classification - Class 2, Special Controls

Product Code BYI Percussor, Powered-electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5665
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 - BYI Percussor, Powered-electric

All 46
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K882604.
EMS PERCUSSOR
K913014 · Engineered Medical Systems · Oct 1991
MJ PERCUSSOR(TM)
K901026 · Merced Medical, Inc. · Mar 1990
FLEX-CUP PERCUSSOR
K892862 · Life Design Systems, Inc. · May 1989
MANUAL PERCUSSOR CUPS
K883899 · Medical Components, Inc. · Dec 1988
SALTER LABS 3000 SERIES PERCUSSORS
K863658 · Salter Labs · Oct 1986
NEONATE PERCUSSOR
K860510 · Ballard Medical Products · Feb 1986
K882604 · PULMO-PATTY
Download PDF Tower Stopper, Inc.