510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800222Substantially Equivalent

Model 412 Electrofluidic Manometer

Med-Tek Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800222 is the FDA 510(k) clearance record for MODEL 412 ELECTROFLUIDIC MANOMETER, a class II device, cleared for Med-Tek Corp. on under FDA product code DXW (System, Phonocatheter, Intracavitary). FDA records list 16 510(k) clearances for Med-Tek Corp., from to . As of , FDA records show no recalls naming K800222.

Clearance record

Decision date
Received
(25 days to decision)
Product code
DXW System, Phonocatheter, Intracavitary
Regulation
21 CFR 870.1270
Device class
Class II
Review panel
Cardiovascular
Applicant
Med-Tek Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DXW

Trailing 12 months

FDA records hold no clearances under product code DXW in the trailing twelve months.

FDA records show no clearances under product code DXW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260