510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K142789Substantially Equivalent

A1c iGear System

Sakae Corporation, Fujioka, Gunma, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142789 is the FDA 510(k) clearance record for A1c iGear System, a class II device, cleared for Sakae Corporation on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list one 510(k) clearance for Sakae Corporation. As of , FDA records show no recalls naming K142789.

Clearance record

Decision date
Received
(81 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Sakae Corporation 239 Onishi, Fujioka, Gunma, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

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