Cleared Traditional

K945850 - BRAUN DIACAN FISTULA NEEDLES

K945850 is an FDA 510(k) clearance for BRAUN DIACAN FISTULA NEEDLES, manufactured by B. Braun of America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K945850 · B. Braun of America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
310d
Days
Class 2
Risk

K945850 is an FDA 510(k) clearance for the BRAUN DIACAN(R) FISTULA NEEDLES. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all B. Braun of America, Inc. devices

FDA 510(k) Submission Details - K945850

510(k) Number K945850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1994
Decision Date October 06, 1995
Days to Decision 310 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 130d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIE Device Classification - Class 2, Special Controls

Product Code FIE Needle, Fistula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIE Needle, Fistula

All 29
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K945850.
NIPRO SAFETOUCH II GAMMA
K063721 · Nipro Medical Corp. · Jan 2007
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · Nipro Medical Corp. · Nov 2000
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
K991623 · Nipro Medical Corp. · Aug 1999
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990
TERUMO AV FISTULA NEEDLE SET
K891062 · Terumo Medical Corp. · Jun 1989
PLUME Y SET
K854951 · Hospal Medical Corp. · Jan 1986