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Filter

by Promedic, Inc.

510(k) K970102

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 NumberK970102 Date24 Jun 1997ClearedStatusActive

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  • Withdrawn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
CAH
Device Class
Class II
Regulation
21 CFR Part 868.5260
Advisory Committee
Anesthesiology
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.

A Filter, Bacterial, Breathing-Circuit is a device intended to remove bacteria and other particulates from breathing circuits in anesthesia and respiratory care settings. It is classified as a Class II medical device under FDA regulation 868.5260 with product code CAH.

The device was cleared via the traditional 510(k) pathway under K970102, granted on June 24, 1997, following a 162-day review. It is manufactured by Promedic, Inc. and is intended for general hospital use in anesthesiology applications.

Other devices from Promedic, Inc.

See all devices from Promedic, Inc. →

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 FILTER Bacterial Breathing-Circuit used for?

    The FILTER Bacterial Breathing-Circuit is intended to remove bacteria and other particulates from breathing circuits in anesthesia and respiratory care settings, as stated in its device description for general hospital use in anesthesiology applications.

  • How was the FILTER Bacterial Breathing-Circuit cleared for market?

    The device was cleared via the traditional 510(k) pathway under K970102, granted on June 24, 1997, following a 162-day review, based on a determination of substantial equivalence to a predicate device.

  • Who manufactures the FILTER Bacterial Breathing-Circuit and where is it made?

    The FILTER Bacterial Breathing-Circuit is manufactured by Promedic, Inc., located at 6329 W. Waterview Ct., Mccordsville, IN 46055, United States, as indicated in the manufacturer and address fields of the device data.