Cleared Traditional

K092313 - PERFUSOR SPACE INFUSION SYRINGE PUMP SY...

K092313 is the FDA 510(k) clearance for PERFUSOR SPACE INFUSION SYRINGE PUMP SY... by B.Braun Medical, Inc.. It is a Class 2 General Hospital device (product code MEA) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K092313 · B.Braun Medical, Inc. · General Hospital
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Nov 2009
Decision
97d
Days
Class 2
Risk

K092313 is an FDA 510(k) clearance for the PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 4, 2009 after a review of 97 days - within the typical 510(k) review window.

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 K092313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2009
Decision Date November 04, 2009
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEA Pump, Infusion, Pca
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 - MEA Pump, Infusion, Pca

All 14
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K092313.
LifeCare PCA Infusion System
K143612 · Hospira, Inc. · Apr 2016
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394 · Smiths Medical Asd, Inc. · Dec 2013
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
K051253 · Baxter Healthcare Corp · Jul 2005
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07
K043256 · Hospira, Inc. · Dec 2004
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042800 · Hospira, Inc. · Oct 2004
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · Baxter Healthcare Corp · Aug 2003