510(k) Report

FDA applicant

Truly Instrument Limited

Shanwei, CN10 decisions2008–20230 recalls

FDA records 10 decisions for Truly Instrument Limited (Shanwei, CN) from 2008 to 2023: 10 510(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 209 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Truly Instrument Co., Ltd.”, “Truly Instrument , Ltd.”.

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 Truly Instrument Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2008: 12009: 32012: 22016: 12017: 12019: 12023: 1
2008high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Truly Instrument Limited by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Truly Instrument Limited’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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive8decisions
  • FLLContinuous Measurement Thermometer2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 209 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 170 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 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.

  • K091434Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63MTruly Instrument Co., Ltd. · 20094cite it
  • K091415Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702MTruly Instrument Co., Ltd. · 20092cite it
  • K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 20162cite it
  • K192023Arm Blood Pressure MonitorTruly Instrument Limited · 20191cites it

What has FDA decided for it lately?

  • K220276Infrared Thermometer TET-351Truly Instrument Limited · 2023
  • K192023Arm Blood Pressure MonitorTruly Instrument Limited · 2019
  • K170545Automatic Wrist Bluetooth Blood Pressure MonitorTruly Instrument, Ltd. · 2017
  • K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited · 2016
  • K113083Truly Automatic Arm Blood Pressure MonitorTruly Instrument Co., Ltd. · 2012
  • K113085Tryly Automatic Wrist Blood Pressure MonitorTruly Instrument Co., Ltd. · 2012
  • K091415Truly Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702MTruly Instrument Co., Ltd. · 2009
  • K091434Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63MTruly Instrument Co., Ltd. · 2009

All 5 as Truly Instrument Limited →All 4 as Truly Instrument Co., Ltd. →The one decision as Truly Instrument, Ltd. →