Cleared Traditional

K023189 - VISTA BASIC WITH FM SYSTEM

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

K023189 · B.Braun Medical, Inc. · General Hospital
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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

Submission Details

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.

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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K023189.
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
K030576 · The Anspach Effort, Inc. · May 2003
ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
K031185 · Abbott Laboratories · Apr 2003
MODIFICATION TO STRYKER PAINPUMP2
K030885 · Stryker Instruments · Apr 2003
ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391
K024084 · Abbott Laboratories · Dec 2002
PARAGON INFUSION SYSTEM WITH BOLUS
K023827 · I-Flow Corp. · Dec 2002
SOAKER CATHETER
K022869 · I-Flow Corp. · Sep 2002