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A Scope

by Active Signal Technologies, Inc.

510(k) K103499

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103499 Date31 Mar 2011ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
DQD
Device Class
Class II
Regulation
21 CFR Part 870.1875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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 A Scope is an electronic stethoscope designed for the detection and amplification of acoustic signals from physiologic activity within the body. It functions as a dual-mode device, enabling clear auscultation in noisy environments by reducing interference and enhancing sound clarity for diagnostic purposes.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as cardiovascular diagnostics. It is not classified as sterile and requires proper cleaning and maintenance between uses. The A Scope holds FDA 510(k) clearance under the traditional review pathway, with a classification of Class II (DQD). It is regulated under the Federal Food, Drug, and Cosmetic Act, specifically under regulation number 870.1875.

Questions

AI-generated answers, 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.

  • What is the A Scope used for?

    The A Scope is an electronic stethoscope designed to detect and amplify acoustic signals from physiologic activity within the body. It is specifically intended for use in clinical settings, particularly for cardiovascular diagnostics, where reducing interference and enhancing sound clarity improve diagnostic accuracy in noisy environments.

  • Is the A Scope reusable or single-use?

    The A Scope is supplied as a reusable medical instrument. Since it is not classified as sterile, proper cleaning and maintenance between uses are required to ensure hygiene and functionality.

  • Does the A Scope require sterilization?

    No, the A Scope is not classified as sterile. It is intended for reusable clinical use and must be cleaned and maintained appropriately between uses to prevent contamination and ensure reliable performance.

  • What regulatory pathway does the A Scope follow?

    The A Scope holds FDA 510(k) clearance under the traditional review pathway. It is classified as Class II (DQD) and is regulated under the Federal Food, Drug, and Cosmetic Act, specifically under regulation number 870.1875.

  • What types of clinical environments is the A Scope suitable for?

    The A Scope is primarily intended for clinical settings where cardiovascular diagnostics are performed. Its electronic design helps reduce environmental noise interference, making it particularly useful in busy or noisy environments where traditional stethoscopes may struggle to provide clear auscultation.