Cleared Traditional

K851058 - DOSI FLOW

K851058 is an FDA 510(k) clearance for DOSI FLOW, manufactured by Leventon, S.A.. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K851058 · Leventon, S.A. · General Hospital
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Apr 1985
Decision
46d
Days
Class 2
Risk

K851058 is an FDA 510(k) clearance for the DOSI FLOW. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Leventon, S.A. (Barcelona, ES). The FDA issued a Cleared decision on April 29, 1985 after a review of 46 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 - K851058

510(k) Number K851058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1985
Decision Date April 29, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 129d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDR Device Classification - Class 2, Special Controls

Product Code LDR Controller, Infusion, Intravascular, Electronic
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 - LDR Controller, Infusion, Intravascular, Electronic

All 31
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K851058.
IVAC FLOW CONTROL ADMINISTRATION SET
K870132 · Y · Feb 1987
FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
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RATEMINDER III INFUSION DEVICE
K855000 · American Edwards Laboratories · Feb 1986
IVAC 280 VOLUMETRIC INFUSION CONTROLLER
K842419 · Y · Aug 1984
A.S.A.P.
K841318 · Trimedyne, Inc. · Jul 1984
ABBOTT LIFECARE 1050 CONTROLLER
K842080 · Abbott Laboratories · Jul 1984