Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CLEARSTAR ENTERAL NUTRITION PUMP

K-Number: K981541 · 1998-08-13

ApplicantFrantz Medical Development, Ltd.
Decision Date1998-08-13
Product CodeLZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLEARSTAR ENTERAL NUTRITION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Frantz Medical Development, Ltd.. It received FDA 510(k) clearance on 1998-08-13 under 510(k) number K981541. The device is classified under product code LZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARSTAR ENTERAL NUTRITION PUMP?

CLEARSTAR ENTERAL NUTRITION PUMP is a medical device that received FDA 510(k) clearance on 1998-08-13. The listed applicant is Frantz Medical Development, Ltd.. The 510(k) number is K981541.

When did CLEARSTAR ENTERAL NUTRITION PUMP receive FDA 510(k) clearance?

CLEARSTAR ENTERAL NUTRITION PUMP received FDA 510(k) clearance on 1998-08-13, under 510(k) number K981541.

Who is the listed applicant for CLEARSTAR ENTERAL NUTRITION PUMP?

The FDA 510(k) record lists Frantz Medical Development, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARSTAR ENTERAL NUTRITION PUMP?

The FDA product code for CLEARSTAR ENTERAL NUTRITION PUMP is LZH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Frantz Medical Development, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K905282ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCEK873119FLEXIFLO COMPANION ENTERAL NUTRITION PUMPK871710BIOPSY FORCEPSK863508FRANTZ MEDICAL ELECTRODE

Related Devices (Code: LZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoahK232205Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed SetVesco Medical, LLCK221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™Cardinal Health, LLCK220230AMSure Enteral Feeding PumpAmsino International, Inc.K200051PUGGLE Enteral Feeding Pump and Feeding SetAmsino International, Inc.K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑