510(k) Report

FDA applicant

Braemar, Inc.

Burnsville, MN10 decisions1995–20085 recalls

FDA records 10 decisions for Braemar, Inc. (Burnsville, MN) from 1995 to 2008: 10 510(k) clearances. Most are in product codes MWJ (Electrocardiograph, Ambulatory (Without…) and DRG (Transmitters And Receivers, Physiological…). Its devices cite 6 predicates, 2 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Braemar Corp.”.

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 Braemar, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 32008: 1
2007high 3 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

3in 2020

2011: 12012: 12020: 3
2007high 3 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Braemar, Inc. 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?

  • MWJElectrocardiograph, Ambulatory (Without Analysis)6decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision
  • DSIDetector And Alarm, Arrhythmia1decision
  • DSHRecorder, Magnetic Tape, Medical1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 2 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.

  • K993617Digitrakplus Holter RecorderBraemar Corp. · 19997cite it
  • K993618DXP1000 Holter RecorderBraemar Corp. · 19996cite it
  • K981394Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 19983cite it
  • K071733DL900 Series Holter RecorderBraemar, Inc. · 20072cite it
  • K081444Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring SystemBraemar, Inc. · 20082cite it
  • K945130Braemar Model DL700 Ambulatory Electrocardiographic RecorderBraemar Corp. · 19952cite it

What has FDA decided for it lately?

  • K081444Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring SystemBraemar, Inc. · 2008
  • K072008Braemar ER900 Wireless Series Arrhythmia Event RecorderBraemar, Inc. · 20072 recalls
  • K071733DL900 Series Holter RecorderBraemar, Inc. · 20073 recalls
  • K071011Modification to: Braemar ER900 Series Enhanced Algorithm Ecg Event RecorderBraemar, Inc. · 2007
  • K042469Braemar ER800 Series Enhanced Algorithm Event RecorderBraemar, Inc. · 2004
  • K030856ER800 Series Ecg Event RecorderBraemar Corp. · 2003
  • K993617Digitrakplus Holter RecorderBraemar Corp. · 1999
  • K993618DXP1000 Holter RecorderBraemar Corp. · 1999

All 5 as Braemar, Inc. →All 5 as Braemar Corp. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K071733Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150…Jan 22, 2020Class II
  • K071733Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150…Jan 22, 2020Class II
  • K071733Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT…Jan 13, 2020Class II
  • K072008Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920…Feb 24, 2012Class II
  • K072008Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920…May 2, 2011Class II

Other applicant names beginning “Braemar”

FDA records each applicant name separately; these may or may not be the same firm.

Braemar Manufacturing, LLC 3