Cleared Traditional

CLEARSTAR ENTERAL NUTRITION PUMP (K981541) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981541 · Frantz Medical Development, Ltd. · General Hospital
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Aug 1998
Decision
106d
Days
Class 2
Risk

K981541 is an FDA 510(k) clearance for the CLEARSTAR ENTERAL NUTRITION PUMP. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Frantz Medical Development, Ltd. (Mentor, US). The FDA issued a Cleared decision on August 13, 1998 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Frantz Medical Development, Ltd. devices

Submission Details

510(k) Number K981541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1998
Decision Date August 13, 1998
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZH Pump, Infusion, Enteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LZH Pump, Infusion, Enteral

All 9
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K981541.
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603 · Cardinal Health, LLC · Dec 2022
AMSure Enteral Feeding Pump
K220230 · Amsino International, Inc. · Nov 2022
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · Amsino International, Inc. · Sep 2020
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · Sherwood Medical Co. · Mar 1995
FLO-GARD 2100 - 2M8281M
K923066 · Baxter Healthcare Corp · May 1993
FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
K913958 · Abbott Laboratories · Feb 1992