Cleared Traditional

K812803 - INFANT PERCUSSOR #5534

K812803 is an FDA 510(k) clearance for INFANT PERCUSSOR #5534, manufactured by Hudson Oxygen Therapy Sales Co.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K812803 · Hudson Oxygen Therapy Sales Co. · Anesthesiology device
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Dec 1981
Decision
58d
Days
Class 2
Risk

K812803 is an FDA 510(k) clearance for the INFANT PERCUSSOR #5534. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Hudson Oxygen Therapy Sales Co. (Walker, US). The FDA issued a Cleared decision on December 3, 1981 after a review of 58 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 Hudson Oxygen Therapy Sales Co. devices

FDA 510(k) Submission Details - K812803

510(k) Number K812803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date December 03, 1981
Days to Decision 58 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
82d faster than avg
Panel avg: 140d · This submission: 58d
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 21
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K812803.
SALTER LABS 3000 SERIES PERCUSSORS
K863658 · Salter Labs · Oct 1986
NEONATE PERCUSSOR
K860510 · Ballard Medical Products · Feb 1986
NEOGUARD CHEST PERCUSSOR
K853965 · Cas Medical Systems, Inc. · Dec 1985
PERCUSSOR
K812166 · Dhd Medical Products Div. Diemolding Corp. · Aug 1981
HAND PERCUSSOR CUP #65210
K802646 · B & F Medical Products, Inc. · Nov 1980
5300 PERCUSSOR
K790675 · Hudson Oxygen Therapy Sales Co. · Apr 1979