510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162564Substantially Equivalent

Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System

Tianjin Empecs Medical Device Co., Ltd., Tianjin, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162564 is the FDA 510(k) clearance record for Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System, a class II device, cleared for Tianjin Empecs Medical Device Co., Ltd. on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 4 510(k) clearances for Tianjin Empecs Medical Device Co., Ltd., from to . As of , FDA records show no recalls naming K162564.

Clearance record

Decision date
Received
(266 days to decision)
Product code
NBW System, Test, Blood Glucose, Over The Counter
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Tianjin Empecs Medical Device Co., Ltd. # 35 And 37, Yingcheng St., Hangu Binhai New Area, Tianjin, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBW

Trailing 12 months
2 clearances under product code NBW in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260