Model 2000 Mild Intermittent Suction Pump

FDA 510(k) K941526 · Product & Educational Services

Substantially Equivalent

510(k) numberK941526

Submission

Device name
Model 2000 Mild Intermittent Suction Pump
Applicant
Product & Educational Services
Dolestown, PA, US
Received
March 30, 1994
Decision date
May 18, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

Other 510(k)s with product code JCX

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K243638MV Flow Aspiration Pump (MVFLOWPMP01)JCX · Traditional Microvention06/13/2025SE
K251111CaryJCX · Traditional Excitus AS05/07/2025SE
K243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingJCX · Special Micro Therapeutics, Inc. d/b/a ev3 Neurovascular12/02/2024SE
K233428Easycess Aspiration PumpJCX · Traditional Guangzhou Easycess Medical Co.,Ltd11/03/2023SE
K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…JCX · Traditional Stryker Instruments12/09/2022SE
K182950Acare Suction UnitJCX · Traditional Acare Technology Co., Ltd.08/23/2019SE
K190789IntelliCartTM SystemJCX · Special Dornoch Medical Systems04/24/2019SE
K190105ZOOM Aspiration PumpJCX · Special Taiwan Biomaterial Co., Ltd.02/21/2019SE
K180115TWBM PumpJCX · Traditional Taiwan Biomaterial Co., Ltd.07/24/2018SE

More from Taiwan Biomaterial Co., Ltd.

510(k)DeviceDecision
K941527Model 2300 General Purpose Suction PumpJCX · Traditional 05/18/1994SE
K941525Model 2200 Thoracic Suction PumpJCX · Traditional 05/18/1994SE
K941524Model 2100 Mild Intermittent Suction PumpJCX · Traditional 05/17/1994SE

Questions and answers

When was Model 2000 Mild Intermittent Suction Pump cleared by the FDA?

Model 2000 Mild Intermittent Suction Pump (K941526) received a 510(k) decision of Substantially Equivalent on May 18, 1994, 49 days after the submission was received.

What is the product code of K941526?

The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.