Cleared Traditional

K040752 - DOSI-FUSER

K040752 is an FDA 510(k) clearance for DOSI-FUSER, manufactured by Leventon, S.A.. The device is a Class 2 General Hospital device with product code MEB cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K040752 · Leventon, S.A. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
14d
Days
Class 2
Risk

K040752 is an FDA 510(k) clearance for the DOSI-FUSER. Classified as Pump, Infusion, Elastomeric (product code MEB), Class II - Special Controls.

Submitted by Leventon, S.A. (Esteve Sesrovires, Barcelona, ES). The FDA issued a Cleared decision on April 7, 2004 after a review of 14 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.

View all Leventon, S.A. devices

FDA 510(k) Submission Details - K040752

510(k) Number K040752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2004
Decision Date April 07, 2004
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MEB Device Classification - Class 2, Special Controls

Product Code MEB Pump, Infusion, Elastomeric
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 - MEB Pump, Infusion, Elastomeric

All 34
Devices cleared under the same product code (MEB) and FDA review panel - the closest regulatory comparables to K040752.
NIPRO SUREFUSER AMBULATORY INFUSION PUMP
K051828 · Nipro Medical Corporation · Dec 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117 · I-Flow Corp. · Sep 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
K040337 · I-Flow Corp. · May 2004
B. BRAUN NERVE BLOCK CATHETER
K030830 · B.Braun Medical, Inc. · Jul 2003
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
K023883 · I-Flow Corp. · Dec 2002
I-FLOW ELASTOMERIC PUMP WITH BOLUS
K023318 · I-Flow Corp. · Oct 2002