Cleared Traditional

K946083 - FLUTTER(R)

K946083 is an FDA 510(k) clearance for FLUTTER, manufactured by Bradstreet Clinical Research Assoc., Inc.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K946083 · Bradstreet Clinical Research Assoc., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
90d
Days
Class 2
Risk

K946083 is an FDA 510(k) clearance for the FLUTTER(R). Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Bradstreet Clinical Research Assoc., Inc. (Brunswick, US). The FDA issued a Cleared decision on March 13, 1995 after a review of 90 days - within the typical 510(k) review window.

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 Bradstreet Clinical Research Assoc., Inc. devices

FDA 510(k) Submission Details - K946083

510(k) Number K946083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1994
Decision Date March 13, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 22
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K946083.
Monarch Airway Clearance System
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K883899 · Medical Components, Inc. · Dec 1988