Cleared Traditional

K060316 - COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS

K060316 is an FDA 510(k) clearance for COMPAT GO ENTERAL FEEDING PUMP AND ADMI..., manufactured by Fresenius Kabi Deutschland GmbH. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K060316 · Fresenius Kabi Deutschland GmbH · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
135d
Days
Class 2
Risk

K060316 is an FDA 510(k) clearance for the COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Fresenius Kabi Deutschland GmbH (Bad Homburg, DE). The FDA issued a Cleared decision on June 23, 2006 after a review of 135 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.

FDA 510(k) Submission Details - K060316

510(k) Number K060316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2006
Decision Date June 23, 2006
Days to Decision 135 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 129d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZH Pump, Infusion, Enteral

All 33
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K060316.
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS
K141479 · Covidien · Dec 2014
ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET
K131154 · Zevex, Inc. · Feb 2014
MEDI-SIS SYRINGE INFUSION SYSTEM
K111381 · Acacia, Inc. · Jan 2012
NOA III ENTERAL NUTRITION PUMP
K040957 · Caesarea Medical Electronics , Ltd. · May 2004
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
K040196 · Tyco Healthcare/Kendall · May 2004
ENTERALITE INFINITY ENTERAL FEEDING PUMP
K031199 · Zevex Intl., Inc. · Jul 2003

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K060316 · COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
Download PDF FDA Summary Fresenius Kabi Deutsc…