Cleared Traditional

K882604 - PULMO-PATTY

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

K882604 · Tower Stopper, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Tower Stopper, Inc. devices

Submission Details

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.

Device Classification

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.