Cleared Traditional

K023189 - VISTA BASIC WITH FM SYSTEM

K023189 is an FDA 510(k) clearance for VISTA BASIC WITH FM SYSTEM, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K023189 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
177d
Days
Class 2
Risk

K023189 is an FDA 510(k) clearance for the VISTA BASIC WITH FM SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Carrollton, US). The FDA issued a Cleared decision on March 20, 2003 after a review of 177 days - an extended review 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: 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K023189

510(k) Number K023189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2002
Decision Date March 20, 2003
Days to Decision 177 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 129d · This submission: 177d
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 586
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K023189.
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K031185 · Abbott Laboratories · Apr 2003
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K030885 · Stryker Instruments · Apr 2003
MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
K030459 · Alaris Medical Systems, Inc. · Apr 2003
FENESTRATED INFUSION CATHETER
K024190 · Promedic, Inc. · Mar 2003
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
K023083 · Mettler Electronics Corp. · Feb 2003
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · Abbott Laboratories · Dec 2002