Cleared Traditional

K883899 - MANUAL PERCUSSOR CUPS

K883899 is an FDA 510(k) clearance for MANUAL PERCUSSOR CUPS, manufactured by Medical Components, Inc.. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K883899 · Medical Components, Inc. · Anesthesiology device
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Dec 1988
Decision
89d
Days
Class 2
Risk

K883899 is an FDA 510(k) clearance for the MANUAL PERCUSSOR CUPS. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Medical Components, Inc. (Anoka, US). The FDA issued a Cleared decision on December 13, 1988 after a review of 89 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 Medical Components, Inc. devices

FDA 510(k) Submission Details - K883899

510(k) Number K883899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1988
Decision Date December 13, 1988
Days to Decision 89 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
51d faster than avg
Panel avg: 140d · This submission: 89d
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 K883899.
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