Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
FMI — Predicate Candidate Screening
691 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
287 days90th percentile
691clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR- | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-08-07 | 140 | 0 |
| K261829 | Profoject™ Dual-Safety Pen Needles | CMT Health PTE., Ltd. | 2026-07-29 | 57 | 0 |
| K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026-07-15 | 131 | 0 |
| K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | 2026-06-10 | 86 | 0 |
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 | 107 | 0 |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easyd | Sandstone Medical (Suzhou), Inc. | 2026-03-25 | 194 | 0 |
| K253047 | PRESSONE™ | Nipro Medical Corporation | 2026-03-24 | 183 | 0 |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 | 120 | 0 |
| K252886 | Pen Needle | Hh Global Technology, Inc. | 2026-01-06 | 118 | 0 |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 2025-11-21 | 259 | 0 |
| K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | 2025-10-16 | 57 | 0 |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | 2025-07-30 | 142 | 0 |
| K250284 | TSK SELECT™ Needle | Tsk Laboratory, Japan | 2025-07-24 | 174 | 0 |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525R | Terumo Europe N.V. | 2025-07-08 | 60 | 0 |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | 2025-05-29 | 220 | 0 |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | 2025-04-18 | 438 | 0 |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | 2025-04-04 | 141 | 0 |
| K250658 | SureFine Pen Needle | Shina Med Corporation | 2025-04-03 | 29 | 0 |
| K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2025-01-10 | 30 | 0 |
| K242741 | ACE Cannula | Ace Medical Industry Co., Ltd. | 2025-01-08 | 119 | 0 |
| K242632 | Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024-09-26 | 23 | 0 |
| K240915 | ZIEN IO Intraosseous Access System | Zien Medical Technologies, Inc. | 2024-07-02 | 90 | 0 |
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hy | Berpu Medical Technology Co., Ltd. | 2024-02-01 | 195 | 0 |
| K233037 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Device Co., Ltd. | 2023-12-12 | 78 | 0 |
| K233343 | SteriCap Safety Needle; VitreJect Safety Needle | Ocuject, LLC | 2023-11-27 | 59 | 0 |
| K230070 | MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Nee | Promamedical, Inc. | 2023-10-05 | 268 | 0 |
| K230043 | Insulin Pen Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-09-20 | 257 | 0 |
| K230959 | VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC | 2023-09-14 | 163 | 0 |
| K231720 | Sterile Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023-09-08 | 87 | 0 |
| K231729 | Sterile syringes for single use with/without needle | Wepon Medical Technology Co., Ltd. | 2023-09-08 | 87 | 0 |
| K231723 | Sterile Safety Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | 2023-09-08 | 87 | 0 |
| K231255 | NovoFine® Plus | Novo Nordisk, Inc. | 2023-08-25 | 116 | 0 |
| K231261 | Altaviz Needle Kit II | Altaviz, LLC | 2023-07-27 | 87 | 0 |
| K231924 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | 2023-07-25 | 25 | 0 |
| K230635 | Pen Needle | Jiangsu Caina Medical Co.,Ltd | 2023-06-02 | 87 | 0 |
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle | Nipro Medical Corporation | 2023-05-25 | 246 | 0 |
| K222739 | Disposable Insulin Pen Needle | Hantech Medical Device Co., Ltd. | 2023-04-06 | 209 | 0 |
| K222417 | Shina Safety Needle | Shina Corporation | 2023-03-20 | 222 | 0 |
| K223327 | Sterile Aesthetic Cannula and Hypodermic Needle | Shanghai Kindly Enterprise Development Group Co., Ltd. | 2023-02-16 | 108 | 0 |
| K222271 | Verisafe Safety sterile needles | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-15 | 201 | 0 |
| K203792 | Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADV | Pikdare Spa | 2023-01-20 | 753 | 0 |
| K223286 | BD AutoShield Duo™ Pen Needle | Becton, Dickinson and Company | 2022-12-28 | 64 | 0 |
| K223334 | Sterile Hypodermic Needles for Single Use | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-12-16 | 45 | 0 |
| K214004 | CCBIO ASCPO Needle | Cc Biotechnology Corporation | 2022-12-13 | 357 | 0 |
| K222681 | Altaviz Needle Kit | Altaviz, LLC | 2022-12-05 | 90 | 1 |
| K223353 | DropSafeTM SicuraTM | Pikdare Spa | 2022-12-02 | 30 | 0 |
| K221178 | Disposable Insulin Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2022-11-17 | 206 | 0 |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic N | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-11-04 | 109 | 0 |
| K220890 | IO Needle Safety Sheath | Actuated Medical, Inc. | 2022-10-31 | 217 | 0 |
| K213183 | Safety Insulin Pen Needles | Zhejiang Kindly Medical Devices Co., Ltd. | 2022-10-14 | 380 | 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