Cleared Traditional

K211121 - Intera Non-coring (Huber) Refill Needles

K211121 is an FDA 510(k) clearance for Intera Non-coring (Huber) Refill Needles, manufactured by Intera Oncology, Inc.. The device is a Class 2 General Hospital device with product code PTI cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K211121 · Intera Oncology, Inc. · General Hospital
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Oct 2021
Decision
182d
Days
Class 2
Risk

K211121 is an FDA 510(k) clearance for the Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special b.... Classified as Non-coring (huber) Needle (product code PTI), Class II - Special Controls.

Submitted by Intera Oncology, Inc. (Wellesley, US). The FDA issued a Cleared decision on October 14, 2021 after a review of 182 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 Intera Oncology, Inc. devices

FDA 510(k) Submission Details - K211121

510(k) Number K211121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2021
Decision Date October 14, 2021
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
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 Consultant

Heyer Regulatory Solutions, LLC
Sheila Hemeon-Heyer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K211121.
PowerLoc™ Max Power Injectable Infusion Set
K241353 · Bard Access Systems, Inc. · Nov 2024
Promisemed Safety Huber Needle
K230715 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2023
Intera Refill Kit
K213823 · Intera Oncology, Inc. · Mar 2022
Huber Needle Infusion Set, Safety Huber Needle Infusion Set
K200463 · Jiangsu Caina Medical Co.,Ltd · Apr 2021
Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
K170897 · B.Braun Medical, Inc. · Nov 2017
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set
K171735 · C.R. Bard, Inc. · Aug 2017