Cleared Traditional

K011868 - ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS

K011868 is an FDA 510(k) clearance for ENTERAL EXPRES PUMP UNIT, manufactured by Debio Tech SA. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K011868 · Debio Tech SA · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
82d
Days
Class 2
Risk

K011868 is an FDA 510(k) clearance for the ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Debio Tech SA (San Diego, US). The FDA issued a Cleared decision on September 4, 2001 after a review of 82 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 - K011868

510(k) Number K011868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2001
Decision Date September 04, 2001
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
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 33
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K011868.
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
ROSS EMBRACE ENTERAL PUMP
K031407 · Ross Product Div. Abbott Laboratories · May 2003
AMBULATORY ENTERAL NUTRITION PUMP
K003047 · Ross Product Div. Abbott Laboratories · Jun 2001
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
K011587 · Entracon Corp. · Jun 2001
CLEARSTAR ENTERAL NUTRITION PUMP
K981541 · Frantz Medical Development, Ltd. · Aug 1998
K011868 · ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS
Download PDF FDA Summary Debio Tech SA