510(k) Report

FDA applicant

Larsen & Toubro Limited

Crofton, MD18 decisions2003–20110 recalls

FDA records 18 decisions for Larsen & Toubro Limited (Crofton, MD) from 2003 to 2011: 18 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and MHX (Monitor, Physiological, Patient (With…). Its devices cite 30 predicates, 16 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 Larsen & Toubro Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007: 12008: 32009: 32010: 12011: 2
2007high 3 (2008) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Larsen & Toubro Limited by year, 2007–2026Sources: 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)15decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)2decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 30 predicates; 16 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 16 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.

  • K080173STAR 55Larsen & Toubro Limited · 20084cite it
  • K051608Star 50 Monitoring SystemLarsen & Toubro Limited · 20054cite it
  • K060058Stellar 404TLarsen & Toubro Limited · 20062cite it
  • K103763Stellar 300Larsen & Toubro Limited · 20112cite it
  • K032871Planet Monitoring SystemLarsen & Toubro Limited · 20032cite it
  • K103686STAR 50 NLarsen & Toubro Limited · 20111cites it

What has FDA decided for it lately?

  • K103686STAR 50 NLarsen & Toubro Limited · 2011
  • K103763Stellar 300Larsen & Toubro Limited · 2011
  • K093017Stellar 300Larsen & Toubro Limited · 2010
  • K092153Skyline 55, Model Ver 1Larsen & Toubro Limited · 2009
  • K090172Star 55 Model 100Larsen & Toubro Limited · 2009
  • K090443Planet 55, Model 100Larsen & Toubro Limited · 2009
  • K082685Galaxy 55Larsen & Toubro Limited · 2008
  • K081552Skyline 55Larsen & Toubro Limited · 2008

All 18 as Larsen & Toubro Limited →