Cleared Traditional

K142596 - Infusomat Space Volumetric Infusion Pump

K142596 is an FDA 510(k) clearance for Infusomat Space Volumetric Infusion Pump, 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 276-day FDA review.

K142596 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
276d
Days
Class 2
Risk

K142596 is an FDA 510(k) clearance for the Infusomat Space Volumetric Infusion Pump. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on June 18, 2015 after a review of 276 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.

FDA 510(k) Submission Details - K142596

510(k) Number K142596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2014
Decision Date June 18, 2015
Days to Decision 276 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
147d slower than avg
Panel avg: 129d · This submission: 276d
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 674
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K142596.
Concert Medical Hands-Free Syringe (HFS)
K153599 · Concert Medical, LLC · Sep 2016
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
K153193 · Zyno Medical, LLC · Aug 2016
Navigator Aesthetic Delivery System
K151255 · Carticept Medical, Inc. · Dec 2015
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
K141789 · Hospira, Inc. · Jan 2015
SAPPHIRE INFUSION PUMP
K141389 · Q Core Medical , Ltd. · Dec 2014
HALO AMBULATORY INFUSION SYSTEM
K140783 · Zyno Medical, LLC · Oct 2014
K142596 · Infusomat Space Volumetric Infusion Pump
Download PDF FDA Summary B.Braun Medical, Inc.