Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PTI — Predicate Candidate Screening
13 FDA 510(k) clearances under this product code; the 50 most recent screened below.
141 daysmedian FDA review time
265 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressu | Sb-Kawasumi Laboratories, Inc. | 2025-11-26 | 120 | 0 |
| K251138 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025-05-13 | 29 | 0 |
| K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025-03-14 | 141 | 0 |
| K241353 | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber | Bard Access Systems, Inc. | 2024-11-27 | 198 | 0 |
| K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2023-06-08 | 85 | 0 |
| K213823 | Intera Refill Kit | Intera Oncology, Inc. | 2022-03-16 | 98 | 0 |
| K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring | Intera Oncology, Inc. | 2021-10-14 | 182 | 0 |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | 2021-04-07 | 407 | 0 |
| K170881 | ISP Safety Huber Needle Infusion Set | Infusion Safety Products, Inc. | 2017-12-14 | 265 | 0 |
| K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan | B.Braun Medical, Inc. | 2017-11-03 | 221 | 0 |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Hube | C.R. Bard, Inc. | 2017-08-08 | 57 | 0 |
| K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set | Medcomp (Dba Medical Components, Inc.) | 2017-07-18 | 71 | 0 |
| K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | 2017-04-26 | 257 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda