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ECG Monitor and Respiration Pacer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K881055

by D. E. Hokanson, Inc.

Identifiers

510(k) Number
K881055 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ECG Monitor and Respiration Pacer is a Class II medical device classified under the FDA’s regulation 870.2340, designated as an electrocardiograph. It is designed to simultaneously monitor electrocardiographic (ECG) signals and regulate respiratory pacing, providing real-time cardiac and respiratory data for clinical assessment.

This device is intended for use in clinical settings, such as hospitals or cardiac care units, where continuous monitoring of both ECG and respiration is required. Supplied as a reusable medical instrument, it requires proper sterilization and maintenance per manufacturer guidelines. The device holds an FDA 510(k) clearance (K881055) under the Cardiovascular advisory committee, with a decision date of August 19, 1988, and is classified under product code DPS.

Frequently asked questions

Is this device intended for single-use or reusable in clinical settings, and what maintenance is required?

This device is designed for reusable use in clinical settings like hospitals or cardiac care units. Since it is reusable, it must undergo proper sterilization and maintenance following the manufacturer’s guidelines to ensure safety and functionality. The manufacturer, D. E. Hokanson, Inc., provides specific protocols for cleaning and sterilization to maintain device integrity between uses.

What types of data does this device monitor, and why might a clinician choose it over a standard ECG monitor?

This device simultaneously monitors electrocardiographic (ECG) signals and provides respiratory pacing regulation, offering real-time cardiac *and* respiratory data. Clinicians may prefer it over a standard ECG monitor when they need continuous assessment of both heart and breathing functions, particularly in critical care settings where respiratory monitoring is essential alongside ECG tracking.

How is this device classified under FDA regulations, and what does that mean for its use in healthcare facilities?

The device is classified as a Class II medical device under FDA regulation 870.2340, specifically designated as an electrocardiograph with the product code DPS. This classification means it undergoes premarket notification (510(k)) review to ensure safety and effectiveness before use. Its FDA 510(k) clearance (K881055) confirms it meets regulatory standards for monitoring ECG and respiratory pacing in clinical settings like hospitals or cardiac care units.

What was the regulatory pathway for this device’s approval, and when was it cleared by the FDA?

This device followed the traditional 510(k) pathway, where the manufacturer demonstrated it was substantially equivalent to a legally marketed predicate device. The FDA’s Cardiovascular (CV) Advisory Committee reviewed it, and it received clearance on August 19, 1988, under the decision code SESE (Substantially Equivalent – Special). The submission was filed on March 8, 1988, and the clearance number is K881055.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ECG MONITOR AND RESPIRATION PACER - Innolitics, ECG MONITOR AND RESPIRATION PACER 510(k) K881055 - FDA.report, PDF K881055 - Ecg Monitor and Respiration Pacer, K973426 - Ans 2000 Ecg Monitor and Respiration Pacer

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
D. E. Hokanson, Inc.

Sources (1)

  • FDA 510(k) K881055 24 fields · synced Oct 6, 2026