Cleared Traditional

K832739 - STEDIFLO INFUSION SET

K832739 is an FDA 510(k) clearance for STEDIFLO INFUSION SET, manufactured by Dravon Medical, Inc.. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K832739 · Dravon Medical, Inc. · General Hospital
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Dec 1983
Decision
129d
Days
Class 2
Risk

K832739 is an FDA 510(k) clearance for the STEDIFLO INFUSION SET. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Dravon Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 129 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.

View all Dravon Medical, Inc. devices

FDA 510(k) Submission Details - K832739

510(k) Number K832739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1983
Decision Date December 22, 1983
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
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 33
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K832739.
TREONIC C30
K840823 · Vickers America Medical Corp. · Mar 1984
MODEL 2001 INTELLIGENT INFUSOR
K834528 · Quest Medical, Inc. · Feb 1984
FLO-GARD 8000 COMPUTER CONTROL INFUSI
K834154 · Travenol Laboratories, S.A. · Jan 1984
KOALA C99 I.V. CONTROLLER
K830780 · Chesebrough-Pond'S U.S.A. Co. · Apr 1983
VOLUMERIC CONTROLLER
K823404 · Quest Medical, Inc. · Dec 1982
380 PIGGYBACK CONTROLLER
K823026 · Imed Corp. · Nov 1982