Cleared Traditional

K131842 - STERICAN CANNULA

K131842 is an FDA 510(k) clearance for STERICAN CANNULA, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K131842 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
60d
Days
Class 2
Risk

K131842 is an FDA 510(k) clearance for the STERICAN CANNULA. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on August 20, 2013 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K131842

510(k) Number K131842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2013
Decision Date August 20, 2013
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 657
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K131842.
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K131358 · Becton, Dickinson & CO · Jul 2013
EXTAVIPRO STERICAN 30G
K131040 · B.Braun Melsungen AG · Jul 2013
CLICKFINE AUTOPROTECT PEN NEEDLE
K131123 · Ypsomed AG · Jul 2013
K131842 · STERICAN CANNULA
Download PDF FDA Summary B.Braun Medical, Inc.