510(k) Report

FDA applicant

Ld Technology, LLC

Miami, FL14 decisions2009–20200 recalls

FDA records 14 decisions for Ld Technology, LLC (Miami, FL) from 2009 to 2020: 14 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and GZO (Device, Galvanic Skin Response Measurement). Since 2016 its 510(k)s took a median of 97 days from receipt to decision, against 165 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 9 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 Ld Technology, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2009: 12010: 22011: 12012: 12013: 22014: 12015: 22016: 12017: 12020: 2
2009high 2 (2010) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Ld Technology, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)4decisions
  • GZODevice, Galvanic Skin Response Measurement3decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive3decisions
  • JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic2decisions
  • DQAOximeter1decision
  • MNWAnalyzer, Body Composition1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 97 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 165 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 21 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 9 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.

  • K102442E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 20102cite it
  • K113264Electro Sensor Complex Software (ES Complex Software)Ld Technology, LLC · 20122cite it
  • K143152TM-ABI systemLd Technology, LLC · 20152cite it
  • K131568Sudo PathLd Technology, LLC · 20131cites it
  • K160956LD-Oxi systemLd Technology, LLC · 20161cites it
  • K200141Oxi-W SystemLd Technology, LLC · 20201cites it

What has FDA decided for it lately?

  • K200287BP-BT KioskLd Technology, LLC · 2020
  • K200141Oxi-W SystemLd Technology, LLC · 2020
  • K173696TBL-ABI SystemLd Technology, LLC · 2017
  • K160956LD-Oxi systemLd Technology, LLC · 2016
  • K152216SudoCLd Technology, LLC · 2015
  • K143152TM-ABI systemLd Technology, LLC · 2015
  • K140412ANS1 SoftwareLd Technology, LLC · 2014
  • K131568Sudo PathLd Technology, LLC · 2013

All 14 as Ld Technology, LLC →