Cleared Traditional

K981541 - CLEARSTAR ENTERAL NUTRITION PUMP

K981541 is an FDA 510(k) clearance for CLEARSTAR ENTERAL NUTRITION PUMP, manufactured by Frantz Medical Development, Ltd.. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K981541

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
Combination Product No
PCCP Authorized No
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.

LZH Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K981541.
MEDI-SIS SYRINGE INFUSION SYSTEM
K111381 · Acacia, Inc. · Jan 2012
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K060316 · Fresenius Kabi Deutschland GmbH · Jun 2006
AMBULATORY ENTERAL NUTRITION PUMP
K003047 · Ross Product Div. Abbott Laboratories · Jun 2001
ENTERALITE
K954735 · Zevex Intl., Inc. · Apr 1996
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
K946168 · Ivac Corporation · Mar 1996
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · Sherwood Medical Co. · Mar 1995