510(k) Report

FDA applicant

Tianjin Empecs Medical Device Co., Ltd.

Manan-Gu Anyang-Si Gyeonggi-Do, KR4 decisions2012–20170 recalls

FDA records 4 decisions for Tianjin Empecs Medical Device Co., Ltd. (Manan-Gu Anyang-Si Gyeonggi-Do, KR) from 2012 to 2017: 4 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Tianjin Empecs Medical Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2012: 12014: 12017: 2
2012high 2 (2017) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Tianjin Empecs Medical Device Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tianjin Empecs Medical Device Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 20122cite it

What has FDA decided for it lately?

  • K162564Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83…Tianjin Empecs Medical Device Co., Ltd. · 2017
  • K152534Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System…Tianjin Empecs Medical Device Co., Ltd. · 2017
  • K133260Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2014
  • K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2012

All 4 as Tianjin Empecs Medical Device Co., Ltd. →