510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K880597Substantially Equivalent

Thumper Model P-1000

Micro Tek Engineering, Centerville OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880597 is the FDA 510(k) clearance record for THUMPER MODEL P-1000, a class II device, cleared for Micro Tek Engineering on under FDA product code BYI (Percussor, Powered-Electric). FDA records list 2 510(k) clearances for Micro Tek Engineering, from to . As of , FDA records show no recalls naming K880597.

Clearance record

Decision date
Received
(47 days to decision)
Product code
BYI Percussor, Powered-Electric
Regulation
21 CFR 868.5665
Device class
Class II
Review panel
Anesthesiology
Applicant
Micro Tek Engineering 8724 Normandy Ln., Centerville OH
Third party review
No

Clearances, product code BYI

Trailing 12 months
1 clearance under product code BYI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BYI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260