Clearstar Enteral Nutrition Pump

FDA 510(k) K981541 · Frantz Medical Development, Ltd.

Substantially Equivalent

510(k) numberK981541

Submission

Device name
Clearstar Enteral Nutrition Pump
Applicant
Frantz Medical Development, Ltd.
Mentor, OH, US
Received
April 29, 1998
Decision date
August 13, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LZH – Pump, Infusion, Enteral
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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K253558Luminoah FLOW™ Enteral Nutrition SystemLZH · Traditional Luminoah04/20/2026SE
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K221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD…LZH · Traditional Cardinal Health, LLC12/20/2022SE
K220230AMSure Enteral Feeding PumpLZH · Traditional Amsino International, Inc.11/10/2022SE
K200051PUGGLE Enteral Feeding Pump and Feeding SetLZH · Traditional Amsino International, Inc.09/25/2020SE
K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…LZH · Traditional Covidien07/06/2016SE
K143263Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsLZH · Traditional Covidien05/29/2015SE
K141479Kangaroo Enteral Feeding Set with Enfit ConnectorsLZH · Traditional Covidien12/23/2014SE
K131154Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral…LZH · Special Zevex, Inc.02/12/2014SE
K111381Medi-Sis Syringe Infusion SystemLZH · Traditional Acacia, Inc.01/13/2012SE

More from Acacia, Inc.

510(k)DeviceDecision
K905282Endoscopic Accessory to the Light SourceGCT · Traditional 03/19/1991SEKD
K873119Flexiflo Companion Enteral Nutrition PumpLZH · Traditional 11/05/1987SE
K871710Biopsy ForcepsFCL · Traditional 08/10/1987SE
K863508Frantz Medical ElectrodeDXR · Traditional 02/06/1987SE

Questions and answers

When was Clearstar Enteral Nutrition Pump cleared by the FDA?

Clearstar Enteral Nutrition Pump (K981541) received a 510(k) decision of Substantially Equivalent on August 13, 1998, 106 days after the submission was received.

What is the product code of K981541?

The FDA product code is LZH – Pump, Infusion, Enteral, a Class II (moderate risk) device regulated under 21 CFR 880.5725.