Cleared Traditional

K011587 - SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP

K011587 is an FDA 510(k) clearance for SENTINEL ENTERAL FEEDING PUMP, manufactured by Entracon Corp.. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K011587 · Entracon Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
9d
Days
Class 2
Risk

K011587 is an FDA 510(k) clearance for the SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Entracon Corp. (Foxborough, US). The FDA issued a Cleared decision on June 1, 2001 after a review of 9 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011587

510(k) Number K011587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2001
Decision Date June 01, 2001
Days to Decision 9 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
120d faster than avg
Panel avg: 129d · This submission: 9d
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

Intertek Testing Services
DONALD J SHERRATT

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 K011587.
ROSS EMBRACE ENTERAL PUMP
K031407 · Ross Product Div. Abbott Laboratories · May 2003
ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
K011868 · Debio Tech SA · Sep 2001
AMBULATORY ENTERAL NUTRITION PUMP
K003047 · Ross Product Div. Abbott Laboratories · Jun 2001
CLEARSTAR ENTERAL NUTRITION PUMP
K981541 · Frantz Medical Development, Ltd. · Aug 1998
ENTERALITE
K954735 · Zevex Intl., Inc. · Apr 1996
IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
K946168 · Ivac Corporation · Mar 1996

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.

K011587 · SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
Download PDF FDA Summary Entracon Corp.