Cleared Traditional

K030739 - INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE

K030739 is an FDA 510(k) clearance for INFUSION DYNAMICS (ID) POWER INFUSER, manufactured by Infusion Dynamics, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K030739 · Infusion Dynamics, Inc. · General Hospital
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Jan 2004
Decision
310d
Days
Class 2
Risk

K030739 is an FDA 510(k) clearance for the INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Infusion Dynamics, Inc. (Frederick, US). The FDA issued a Cleared decision on January 14, 2004 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K030739

510(k) Number K030739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2003
Decision Date January 14, 2004
Days to Decision 310 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 129d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
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 - FRN Pump, Infusion

All 727
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K030739.
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K040899 · Medex, Inc. · Apr 2004
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
K040061 · Medtronic Minimed · Apr 2004
ABBOTT DATA PORT PC, MODEL 12181
K040114 · Abbott Laboratories · Jan 2004
AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
K033325 · Sorenson Medical, Inc. · Nov 2003
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
K033425 · Sorenson Medical, Inc. · Nov 2003
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469
K032789 · American I.V. Products, Inc. · Oct 2003
K030739 · INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
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