Cleared Traditional

BI-PHASIC INFILTRATOR (K012044) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012044 · Reliance Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 221
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K012044.
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · Abbott Laboratories · Dec 2002
ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348
K021350 · Abbott Laboratories · May 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · Smith & Nephew, Inc. · Apr 2002
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · Abbott Laboratories · Jun 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · Baxter Healthcare Corp · May 2001
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · Abbott Laboratories · May 2001