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Impact Models 701, 702 and 703 - 701

by Impact Instrumentation, Inc.

510(k) K861272

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 NumberK861272 Date20 May 1986ClearedStatusActive

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  • Withdrawn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
BTL
Models / Variants
701
Device Class
Class II
Regulation
21 CFR Part 868.5925
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Impact Models 701, 702 and 703 are ventilators, emergency, powered, also known as resuscitators. They are classified as Class II devices with special controls. The device is substantially equivalent to other devices on the market.

The Impact Models 701, 702 and 703 are supplied by Impact Instrumentation, Inc. and have been cleared by the FDA with a 510(k) clearance, K number K861272. The device is regulated under product code BTL and regulation number 868.5925. It is intended for use in anesthesiology.

Other devices from Impact Instrumentation, Inc.

See all devices from Impact Instrumentation, Inc. →

Questions

AI-generated answers, 24 Sep 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 intended use of the Impact Models 701, 702 and 703?

    The Impact Models 701, 702 and 703 are intended for use in anesthesiology as emergency powered ventilators, also known as resuscitators.

  • What is the regulatory classification of the device?

    The Impact Models 701, 702 and 703 are classified as Class II devices with special controls, regulated under product code BTL and regulation number 868.5925.

  • What is the clearance status of the device?

    The Impact Models 701, 702 and 703 have been cleared by the FDA with a 510(k) clearance, K number K861272.

  • What type of device is the Impact Model 701?

    The Impact Model 701 is a ventilator, specifically an emergency powered ventilator, also known as a resuscitator.