Cleared Traditional

K012044 - BI-PHASIC INFILTRATOR

K012044 is an FDA 510(k) clearance for BI-PHASIC INFILTRATOR, manufactured by Reliance Medical Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K012044 · Reliance Medical Corp. · General Hospital
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Aug 2001
Decision
60d
Days
Class 2
Risk

K012044 is an FDA 510(k) clearance for the BI-PHASIC INFILTRATOR. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Reliance Medical Corp. (Grand Junction, US). The FDA issued a Cleared decision on August 28, 2001 after a review of 60 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 Reliance Medical Corp. devices

FDA 510(k) Submission Details - K012044

510(k) Number K012044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2001
Decision Date August 28, 2001
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
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 566
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K012044.
SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP
K013767 · Sterling Medivations, Inc. · Dec 2001
GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
K012383 · Alaris Medical Systems, Inc. · Oct 2001
HORIZON OUTLOOK WITH DOSECOM
K011975 · B.Braun Medical, Inc. · Sep 2001
STRYKER PAINPUMP PCA
K003543 · Stryker Instruments · Jun 2001
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · Abbott Laboratories · Jun 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · Baxter Healthcare Corp · May 2001