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IPG-300

by Thornton Associates, Inc.

510(k) K852238

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 NumberK852238 Date11 Oct 1985ClearedStatusActive

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  • Withdrawn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
DSB
Device Class
Class II
Regulation
21 CFR Part 870.2770
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 IPG-300 is an impedance plethysmograph, a device used to measure changes in blood flow or volume in peripheral limbs or other body parts through electrical impedance techniques. It is classified as a Class II medical device under FDA regulation 870.2770 and has the product code DSB.

The IPG-300 received traditional 510(k) clearance (K852238) from the FDA on October 11, 1985, following a determination of substantial equivalence. It was submitted by Thornton Associates, Inc. and reviewed by the Cardiovascular advisory committee. The device is intended for use in cardiovascular applications.

Other devices from Thornton Associates, Inc.

  • Spiral

    Class II

Questions

AI-generated answers, 6 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 IPG-300 used for?

    The IPG-300 is an impedance plethysmograph designed to measure changes in blood flow or volume in peripheral limbs or other body parts using electrical impedance techniques, intended for cardiovascular applications as specified in its FDA 510(k) clearance.

  • How is the IPG-300 supplied and is it reusable?

    The IPG-300 is a reusable electronic instrument; the device data does not specify disposable components or single-use accessories, indicating it is intended for repeated use in clinical settings after appropriate cleaning and maintenance.

  • What regulatory pathway was used for the IPG-300?

    The IPG-300 received traditional 510(k) clearance (K852238) from the FDA on October 11, 1985, based on a determination of substantial equivalence to a legally marketed predicate device.