Holter Scanner (K881488)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Holter Scanner

510(k) Number

K881488 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model SSR1 Holter Monitor

  Class II

  FDA 510(k) K873337 Active Cleared 9 Oct 1987

• Cardiodata Pace Recorder

  Class II

  FDA 510(k) K834257 Active Cleared 30 Jan 1984

• Paceguard

  Class II

  FDA 510(k) K770264 Active Cleared 16 Feb 1977

• Cardio-Data System, #mark III

  Class II

  FDA 510(k) K812149 Active Cleared 31 Aug 1981

• Cardio Data MK4 Holter Analysis System

  Class II

  FDA 510(k) K850136 Active Cleared 1 Feb 1985

• Cardio Data Pacerecorder PR3

  Class II

  FDA 510(k) K853262 Active Cleared 11 Oct 1985

See all devices from Cardio Data →

• What is the primary purpose of the Holter Scanner, and how does it function in a clinical setting?

  The Holter Scanner is designed as a Detector and Alarm for Arrhythmia (Device Class II) to continuously monitor and analyze cardiac electrical activity recorded by a Holter monitor. It processes data over extended periods to detect abnormal heart rhythms, such as arrhythmias, and alerts clinicians to potential issues, enabling timely intervention.

• Is the Holter Scanner reusable, and if so, what does this mean for maintenance and usage?

  Yes, the Holter Scanner is supplied as a reusable system, meaning it is intended for repeated use across multiple patients. This implies that proper cleaning, disinfection, and maintenance protocols must be followed to ensure reliability, safety, and compliance with clinical standards. The device integrates with software, so software updates or recalibration may also be required.

• What regulatory pathway was followed for FDA clearance of the Holter Scanner, and what does this indicate about its safety and effectiveness?

  The Holter Scanner received FDA 510(k) clearance (K881488) under the Traditional pathway, with a decision labeled as *Substantially Equivalent* to a predicate device. This indicates that the FDA determined it met the same safety and performance criteria as an existing, legally marketed device in the same category, specifically under the Cardiovascular specialty (DSI product code). This pathway does not imply new breakthrough technology but confirms compliance with regulatory standards.

• Are there any specific storage requirements or considerations for the Holter Scanner?

  The provided data does not specify sterility or MRI safety requirements for the Holter Scanner. However, since it is a reusable device, proper storage conditions—such as protection from moisture, dust, and extreme temperatures—are critical to maintain functionality and hygiene. Clinicians should follow manufacturer guidelines for storage to ensure optimal performance and longevity.

• How would a clinician determine if the Holter Scanner is compatible with their existing Holter monitoring systems?

  The Holter Scanner is designed for software integration with Holter monitors, but the exact compatibility details (e.g., data formats, connectivity standards) are not provided in the data. Clinicians should consult Cardiodata Corp. or refer to the device’s technical documentation to confirm compatibility with their specific Holter monitoring systems before use. The manufacturer’s contact (BETTY LANE at 71 Lyman St., Northborough, MA 01532) may also provide guidance.