Cleared Traditional

K880597 - THUMPER MODEL P-1000

K880597 is an FDA 510(k) clearance for THUMPER MODEL P-1000, manufactured by Micro Tek Engineering. The device is a Class 2 Anesthesiology device with product code BYI cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K880597 · Micro Tek Engineering · Anesthesiology device
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Mar 1988
Decision
47d
Days
Class 2
Risk

K880597 is an FDA 510(k) clearance for the THUMPER MODEL P-1000. Classified as Percussor, Powered-electric (product code BYI), Class II - Special Controls.

Submitted by Micro Tek Engineering (Centerville, US). The FDA issued a Cleared decision on March 29, 1988 after a review of 47 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 Micro Tek Engineering devices

FDA 510(k) Submission Details - K880597

510(k) Number K880597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1988
Decision Date March 29, 1988
Days to Decision 47 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 140d · This submission: 47d
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 37
Devices cleared under the same product code (BYI) and FDA review panel - the closest regulatory comparables to K880597.
EMS PERCUSSOR
K913014 · Engineered Medical Systems · Oct 1991
FLEX-CUP PERCUSSOR
K892862 · Life Design Systems, Inc. · May 1989
MANUAL PERCUSSOR CUPS
K883899 · Medical Components, Inc. · Dec 1988
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