Atlas FDA

PTI

13 FDA 510(k) clearances · Product code

141 daysmedian time to decision
265 days90th percentile
13clearances measured

FDA profile

Official device name
Non-Coring (Huber) Needle
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5570
Medical specialty
General Hospital
FDA 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.
Adverse events (MAUDE)
2020: 13 · 2021: 17 · 2024: 36 · 2025: 33 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (K252355)Sb-Kawasumi Laboratories, Inc.2025-11-26
Promisemed Safety Huber Needles (K251138)Promisemed Hangzhou Meditech Co., Ltd.2025-05-13
Promisemed Safety Huber Needles (K243332)Promisemed Hangzhou Meditech Co., Ltd.2025-03-14
PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set (K241353)Bard Access Systems, Inc.2024-11-27
Promisemed Safety Huber Needle (K230715)Promisemed Hangzhou Meditech Co., Ltd.2023-06-08
Intera Refill Kit (K213823)Intera Oncology, Inc.2022-03-16
Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit (K211121)Intera Oncology, Inc.2021-10-14
Huber Needle Infusion Set, Safety Huber Needle Infusion Set (K200463)Jiangsu Caina Medical Co.,Ltd2021-04-07
ISP Safety Huber Needle Infusion Set (K170881)Infusion Safety Products, Inc.2017-12-14
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.2017-11-03
PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set (K171735)C.R. Bard, Inc.2017-08-08
20G x 5/8 Pro-Lock CT Safety Infusion Set (K171333)Medcomp (Dba Medical Components, Inc.)2017-07-18
Pro-Lock CT Safety Infusion Set (K162271)Medcomp (Medical Components, Inc.)2017-04-26

Track PTI automatically

Every clearance here is in the API, with alerts when new ones post.