Cleared Traditional

K965192 - THAIRAPY VEST SYSTEM

K965192 is an FDA 510(k) clearance for THAIRAPY VEST SYSTEM, manufactured by American Biosystems, Inc.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K965192 · American Biosystems, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
182d
Days
Class 2
Risk

K965192 is an FDA 510(k) clearance for the THAIRAPY VEST SYSTEM. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by American Biosystems, Inc. (St.Paul, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 182 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 - K965192

510(k) Number K965192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1996
Decision Date June 24, 1997
Days to Decision 182 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
42d slower than avg
Panel avg: 140d · This submission: 182d
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 K965192.
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
K982889 · Electromed, Inc. · Jun 1999
X-AIR-CISER
K974849 · Hougen Mfg., Inc. · Aug 1998
FLUTTER D
K972859 · Bradstreet Clinical Research Assoc., Inc. · Jun 1998
FLUTTER(R)
K946083 · Bradstreet Clinical Research Assoc., Inc. · Mar 1995
3P (PULMONARY PERCUSSIVE PACK)
K931988 · Delta Medical Manuf, Inc. · Oct 1994
THAIRAPY SYSTEM
K936121 · American Biosystems, Inc. · Aug 1994
K965192 · THAIRAPY VEST SYSTEM
Download PDF FDA Summary American Biosystems, …