Cleared Traditional

K863658 - SALTER LABS 3000 SERIES PERCUSSORS

K863658 is an FDA 510(k) clearance for SALTER LABS 3000 SERIES PERCUSSORS, manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K863658 · Salter Labs · Anesthesiology device
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Oct 1986
Decision
18d
Days
Class 2
Risk

K863658 is an FDA 510(k) clearance for the SALTER LABS 3000 SERIES PERCUSSORS. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on October 6, 1986 after a review of 18 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 Salter Labs devices

FDA 510(k) Submission Details - K863658

510(k) Number K863658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1986
Decision Date October 06, 1986
Days to Decision 18 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
122d faster than avg
Panel avg: 140d · This submission: 18d
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 17
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K863658.
Monarch Airway Clearance System
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FLEX-CUP PERCUSSOR
K892862 · Life Design Systems, Inc. · May 1989
MANUAL PERCUSSOR CUPS
K883899 · Medical Components, Inc. · Dec 1988
NEONATE PERCUSSOR
K860510 · Ballard Medical Products · Feb 1986
NEOGUARD CHEST PERCUSSOR
K853965 · Cas Medical Systems, Inc. · Dec 1985
INFANT PERCUSSOR #5534
K812803 · Hudson Oxygen Therapy Sales Co. · Dec 1981