Braemar Manufacturing, LLC
Eagan, MN, US
BRAEMAR MANUFACTURING, LLC appears in FDA device records in Eagan, MN. FDA records list 13 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Braemar Manufacturing, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Braemar, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 13 510(k) clearances for Braemar Manufacturing, LLC between 1995 and 2018. The busiest year on record is 2007, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2007 | 3 |
| 2008 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171410 | ePatch | DSH | Substantially Equivalent | |
| K153473 | Braemar Telemetry Patch System | DSI | Substantially Equivalent | |
| K130294 | BRAEMAR CARDIOKEY HOLTER RECORDER | MWJ | Substantially Equivalent | |
| K081444 | BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM | DSI | Substantially Equivalent | |
| K072008 | BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER | DRG | Substantially Equivalent | |
| K071733 | DL900 SERIES HOLTER RECORDER | MWJ | Substantially Equivalent | |
| K071011 | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER | MWJ | Substantially Equivalent | |
| K042469 | BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER | MWJ | Substantially Equivalent | |
| K030856 | ER800 SERIES ECG EVENT RECORDER | MWJ | Substantially Equivalent | |
| K993618 | DXP1000 HOLTER RECORDER | MWJ | Substantially Equivalent | |
| K993617 | DIGITRAKPLUS HOLTER RECORDER | MWJ | Substantially Equivalent | |
| K981394 | BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 | DXH | Substantially Equivalent | |
| K945130 | BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER | DSH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2133409 | 1000520785 | BRAEMAR MANUFACTURING, LLC | 1285 Corporate Center Dr Ste 150, EAGAN, MN 55121 US | 2026 | |
| 3003584029 | 3003584029 | Braemar Manufacturing, LLC | 3721 Valley Centre Drive, Suite 100, San Diego, CA 92130 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0708-2025 | Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices. | Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software. | Class I | Open, Classified | |
| Z-1460-2020 | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in the recorder and a user attempts to start it, the recorder will display Error: 602 and fail to function for a new patient study. There are no actions that a clinical user can take to clear this error. Even if this error code is displayed, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software. Error 602 may be able to be cleared by technical or engineering staff at the customer site. | Class II | Terminated | |
| Z-1459-2020 | Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only | An issue with the DL900 and DL950 Series Holter Recorder was recognized on January 1, 2020. This issue can prevent the recorder from operating normally. Braemar confirmed that beginning on January 1, 2020 if a AAA battery is inserted in the recorder and a user attempts to start it, the recorder will display Error: 602 and fail to function for a new patient study. There are no actions that a clinical user can take to clear this error. Even if this error code is displayed, existing ECG recordings stored on the device can still be downloaded via the standard Holter Application Software. Error 602 may be able to be cleared by technical or engineering staff at the customer site. | Class II | Terminated | |
| Z-1652-2013 | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack. | Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact. | Class II | Terminated | |
| Z-1645-2013 | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack. | Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related injury or present any clinical impact. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain