510(k) Report

FDA applicant

Braun GmbH

Carlsbad, CA9 decisions1985–20060 recalls

FDA records 9 decisions for Braun GmbH (Carlsbad, CA) from 1985 to 2006: 9 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and JEQ (Toothbrush, Powered). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Braun AG”, “The Braun Corp.”.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Braun GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Braun GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Braun GmbH’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?

  • FLLContinuous Measurement Thermometer4decisions
  • JEQToothbrush, Powered2decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • EFSUnit, Oral Irrigation1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 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.

  • K983295Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520Braun AG · 19999cite it
  • K031928Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt 4000 Series (Home Use…Braun GmbH · 20034cite it
  • K061199Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH · 20061cites it
  • K061351Oral-B Sonic CompleteBraun GmbH · 20061cites it
  • K003732Braun Precision Sensor, Model BP 2000 SeriesBraun GmbH · 20011cites it

What has FDA decided for it lately?

  • K061351Oral-B Sonic CompleteBraun GmbH · 2006
  • K061199Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH · 2006
  • K060006Braun Thermoscan Irt 2000 Infrared Ear ThermometerBraun GmbH · 2006
  • K031928Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt 4000 Series (Home Use…Braun GmbH · 2003
  • K012035Braun Precision Sensor Pro, Model BP 2590Braun GmbH · 2001
  • K003732Braun Precision Sensor, Model BP 2000 SeriesBraun GmbH · 2001
  • K992468Braun Thermoscan PRO3000 Infared ThermometerBraun GmbH · 1999
  • K983295Braun Thermoscan IRT3020/3500 One Secons Ear Thermometer, Model IRT3020/3520Braun AG · 1999

All 7 as Braun GmbH →The one decision as Braun AG →The one decision as The Braun Corp. →