510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982612Substantially Equivalent

Esp7 Venous Image

Ironmaster, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982612 is the FDA 510(k) clearance record for ESP7 VENOUS IMAGE, a class I device, cleared for Ironmaster, Inc. on under FDA product code KZA (Device, Vein Location, Liquid Crystal). FDA records list one 510(k) clearance for Ironmaster, Inc. As of , FDA records show no recalls naming K982612.

Clearance record

Decision date
Received
(140 days to decision)
Product code
KZA Device, Vein Location, Liquid Crystal
Regulation
21 CFR 880.6970
Device class
Class I
Review panel
General Hospital
Applicant
Ironmaster, Inc. 1719 Grant St., Santa Clara CA
510(k) summary
Summary
Third party review
No

Clearances, product code KZA

Trailing 12 months

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

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