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Compumedics Summit IP

by Compumedics USA, Ltd.

510(k) K040194

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040194 Date23 Apr 2004ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MNR
Device class
Class II
Regulation
21 CFR Part 868.2375
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Compumedics Summit IP is a Ventilatory Effort Recorder, designed to measure respiratory effort during clinical assessments. It functions as a portable device that interfaces with thoracic and abdominal effort bands to monitor inspiratory and expiratory efforts, generating signals for thoracic, abdominal, and summed respiratory activity. This data is critical for evaluating respiratory mechanics, particularly in settings such as sleep studies or anesthesia monitoring.

The Summit IP is supplied as a reusable, non-sterile device intended for use in clinical environments such as hospitals or research facilities. It operates in non-MRI environments and is not intended for single-patient use. The device adheres to FDA 510(k) clearance under the Anesthesiology advisory committee, classified as a Class II medical device under regulation 21 CFR 868.2375. It requires proper calibration and maintenance as specified by the manufacturer.

Similar devices

Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).

Other devices from Compumedics USA, Inc.