Cleared Traditional

K802646 - HAND PERCUSSOR CUP #65210

K802646 is an FDA 510(k) clearance for HAND PERCUSSOR CUP #65210, manufactured by B & F Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K802646 · B & F Medical Products, Inc. · Anesthesiology device
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Nov 1980
Decision
19d
Days
Class 2
Risk

K802646 is an FDA 510(k) clearance for the HAND PERCUSSOR CUP #65210. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by B & F Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 19 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B & F Medical Products, Inc. devices

FDA 510(k) Submission Details - K802646

510(k) Number K802646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1980
Decision Date November 12, 1980
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
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 19
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K802646.
NEOGUARD CHEST PERCUSSOR
K853965 · Cas Medical Systems, Inc. · Dec 1985
INFANT PERCUSSOR #5534
K812803 · Hudson Oxygen Therapy Sales Co. · Dec 1981
PERCUSSOR
K812166 · Dhd Medical Products Div. Diemolding Corp. · Aug 1981
5300 PERCUSSOR
K790675 · Hudson Oxygen Therapy Sales Co. · Apr 1979
ARGYLE PEOCUSSOR SYSTEM
K771876 · Sherwood Medical Industries · Oct 1977