510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760846Substantially Equivalent

Pakostat II

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

K760846 is the FDA 510(k) clearance record for PAKOSTAT II, a class II device, cleared for Pako Corp. on under FDA product code EGW (Dryer, Film, Radiographic). FDA records list one 510(k) clearance for Pako Corp. As of , FDA records show no recalls naming K760846.

Clearance record

Decision date
Received
(84 days to decision)
Product code
EGW Dryer, Film, Radiographic
Regulation
21 CFR 892.1900
Device class
Class II
Review panel
Radiology
Applicant
Pako Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EGW

Trailing 12 months

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

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