510(k) Report

FDA applicant

Orantech, Inc.

Shenzhen, CN5 decisions2018–20190 recalls

FDA records 5 decisions for Orantech, Inc. (Shenzhen, CN) from 2018 to 2019: 5 510(k) clearances. Most are in product codes CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) and DXQ (Blood Pressure Cuff). Since 2016 its 510(k)s took a median of 323 days from receipt to decision, against 225 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 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, cardiovascular panel, where it files most

How often FDA has decided Orantech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 42019: 1
2018high 4 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Orantech, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orantech, Inc.’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?

  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision
  • DXQBlood Pressure Cuff1decision
  • DSACable, Transducer And Electrode, Patient, (Including Connector)1decision
  • FLLContinuous Measurement Thermometer1decision
  • DQAOximeter1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 323 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 225 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K173197Reusable NIBP CuffOrantech, Inc. · 20181cites it
  • K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc. · 20181cites it

What has FDA decided for it lately?

  • K182327Patient Cables and Leadwires , Disposable ECG LeadwiresOrantech, Inc. · 2019
  • K173194Temperature ProbeOrantech, Inc. · 2018
  • K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc. · 2018
  • K173197Reusable NIBP CuffOrantech, Inc. · 2018
  • K171828ETCO2 SensorOrantech, Inc. · 2018

All 5 as Orantech, Inc. →