Skip to content

Bubble Trap Cat. No. B-180

by American Omni Medical, Inc.

510(k) K870819

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 NumberK870819 Date8 Jun 1987ClearedStatusActive

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  • Withdrawn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
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Bubble Trap Cat. No. B-180 is a cardiopulmonary bypass device classified as a catheter, cannula, and tubing. It is designed to function as a bubble trap within a cardiopulmonary bypass circuit.

This device is authorized under FDA 510(k) clearance K870819. It is manufactured by American Omni Medical, Inc.

Other devices from American Omni Medical, Inc.

See all devices from American Omni Medical, Inc. →

Questions

AI-generated answers, 22 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 primary function of the Bubble Trap Cat. No. B-180?

    The device is designed to function as a bubble trap specifically for use within a cardiopulmonary bypass circuit.

  • What is the regulatory status of this device?

    The Bubble Trap Cat. No. B-180 is authorized under FDA 510(k) clearance K870819, which indicates it has been found substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of this bubble trap?

    This device is manufactured by American Omni Medical, Inc., located in Costa Mesa, California.