510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790302Substantially Equivalent

Pressure Monitor, Model 212

Zatek, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790302 is the FDA 510(k) clearance record for PRESSURE MONITOR, MODEL 212, a class I device, cleared for Zatek on under FDA product code HRW (Dynamometer, Nonpowered). FDA records list one 510(k) clearance for Zatek. As of , FDA records show no recalls naming K790302.

Clearance record

Decision date
Received
(36 days to decision)
Product code
HRW Dynamometer, Nonpowered
Regulation
21 CFR 888.1250
Device class
Class I
Review panel
Orthopedic
Applicant
Zatek 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HRW

Trailing 12 months

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

FDA records show no clearances under product code HRW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HRW, 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