Cleared Traditional

K972859 - FLUTTER D

K972859 is an FDA 510(k) clearance for FLUTTER D, 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 305-day FDA review.

K972859 · Bradstreet Clinical Research Assoc., Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
305d
Days
Class 2
Risk

K972859 is an FDA 510(k) clearance for the FLUTTER D. 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 June 5, 1998 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K972859

510(k) Number K972859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1997
Decision Date June 05, 1998
Days to Decision 305 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
165d slower than avg
Panel avg: 140d · This submission: 305d
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 K972859.
ABI VEST AIRWAY CLEARANCE SYSTEM
K993629 · American Biosystems, Inc. · Jan 2000
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
K982889 · Electromed, Inc. · Jun 1999
X-AIR-CISER
K974849 · Hougen Mfg., Inc. · Aug 1998
THAIRAPY VEST SYSTEM
K965192 · American Biosystems, Inc. · Jun 1997
FLUTTER(R)
K946083 · Bradstreet Clinical Research Assoc., Inc. · Mar 1995
3P (PULMONARY PERCUSSIVE PACK)
K931988 · Delta Medical Manuf, Inc. · Oct 1994
K972859 · FLUTTER D
Download PDF FDA Summary Bradstreet Clinical R…