510(k) Report

FDA applicant

Dongguan E-Test Technology Co., Ltd.

Dongguan, CN5 decisions2020–20254 recalls

FDA records 5 decisions for Dongguan E-Test Technology Co., Ltd. (Dongguan, CN) from 2020 to 2025: 5 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 199 days from receipt to decision, against 198 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Dongguan E-Test Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 42025: 1
2020high 4 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

4in 2024

2024: 4
2020high 4 (2024) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Dongguan E-Test Technology Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive4decisions
  • FLLContinuous Measurement Thermometer1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 199 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 198 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193627Automatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 20202cite it
  • K193628AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 20201cites it

What has FDA decided for it lately?

  • K250231Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X…Dongguan E-Test Technology Co., Ltd. · 2025
  • K193621Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)Dongguan E-Test Technology Co., Ltd. · 2020
  • K193627Automatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 20204 recalls
  • K193628AGE Automatic Wrist Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020
  • K193624Automatic Upper Arm Blood Pressure MonitorDongguan E-Test Technology Co., Ltd. · 2020

All 5 as Dongguan E-Test Technology Co., Ltd. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K193627Medline Automatic Digital Blood Pressure Unit, Ref MDS1001Aug 30, 2024Class II
  • K193627MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.Aug 30, 2024Class II
  • K193627Medline Automatic Digital Blood Pressure Unit, Ref MDS1001U.Aug 30, 2024Class II
  • K193627Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUSFeb 26, 2024Class II