Cleared Traditional

K170897 - Surecan Safety II Needle

K170897 is an FDA 510(k) clearance for Surecan Safety II Needle, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code PTI cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K170897 · B.Braun Medical, Inc. · General Hospital
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Nov 2017
Decision
221d
Days
Class 2
Risk

K170897 is an FDA 510(k) clearance for the Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle .... Classified as Non-coring (huber) Needle (product code PTI), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 3, 2017 after a review of 221 days - an extended review 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: 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

FDA 510(k) Submission Details - K170897

510(k) Number K170897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2017
Decision Date November 03, 2017
Days to Decision 221 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
92d slower than avg
Panel avg: 129d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PTI Device Classification - Class 2, Special Controls

Product Code PTI Non-coring (huber) Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition The Non-coring Needle (huber) Is Utilized To Gain Access Into A Subcutaneous Implanted Intravascular Infusion Port But Can Also Be Used To Access Other Non-vascular Implanted Devices With Similar Septums.
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 - PTI Non-coring (huber) Needle

All 9
Devices cleared under the same product code (PTI) and FDA review panel - the closest regulatory comparables to K170897.
Intera Refill Kit
K213823 · Intera Oncology, Inc. · Mar 2022
Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
K211121 · Intera Oncology, Inc. · Oct 2021
Huber Needle Infusion Set, Safety Huber Needle Infusion Set
K200463 · Jiangsu Caina Medical Co.,Ltd · Apr 2021
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
K171735 · C.R. Bard, Inc. · Aug 2017