Cleared Traditional

K140838 - IV ADMINISTRATION SET WITH HAND PUMP

K140838 is the FDA 510(k) clearance for IV ADMINISTRATION SET WITH HAND PUMP by B.Braun Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K140838 · B.Braun Medical, Inc. · General Hospital
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Dec 2014
Decision
247d
Days
Class 2
Risk

K140838 is an FDA 510(k) clearance for the IV ADMINISTRATION SET WITH HAND PUMP. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on December 5, 2014 after a review of 247 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 K140838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2014
Decision Date December 05, 2014
Days to Decision 247 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
118d slower than avg
Panel avg: 129d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 278
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K140838.
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INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036 · B.Braun Medical, Inc. · Aug 2014
CARESITE LUER ACCESS DEVICE
K140311 · B.Braun Medical, Inc. · May 2014
NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
K132734 · Baxter Healthcare Corp · Oct 2013