Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMF — Predicate Candidate Screening
749 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
267 days90th percentile
749clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026-07-13 | 171 | 0 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syring | Sol-Millennium Medical, Inc. | 2026-06-18 | 267 | 0 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Nee | CMT Health PTE., Ltd. | 2026-06-12 | 115 | 0 |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with | Hlb Lifescience Co., Ltd. | 2026-05-21 | 239 | 0 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, | Chirana T.Injecta,A.S. | 2026-04-17 | 269 | 0 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable | CMT Health PTE., Ltd. | 2026-02-23 | 154 | 0 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 | 27 | 0 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 | 128 | 0 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle | Exelint International, Co. | 2025-12-12 | 246 | 0 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 | 321 | 0 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 | 228 | 0 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 | 236 | 0 |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); | Cardinalhealth | 2025-08-22 | 268 | 0 |
| K251350 | BD Plastipak™ Syringe | Becton, Dickinson and Company | 2025-07-29 | 90 | 0 |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe | CMT Health PTE., Ltd. | 2025-07-25 | 25 | 0 |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 | 114 | 0 |
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | 2025-06-24 | 26 | 0 |
| K250262 | GO-PEN® | Go-Pen Aps | 2025-04-24 | 85 | 0 |
| K243580 | GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC | 2025-02-05 | 78 | 0 |
| K242434 | Insulin Syringes | Chirana T. Injecta | 2024-12-24 | 130 | 0 |
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with | Hlb Lifescience Co., Ltd. | 2024-12-23 | 179 | 0 |
| K242099 | Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip | Sol-Millennium Medical, Inc. | 2024-10-22 | 96 | 0 |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with | Sol-Millennium Medical, Inc. | 2024-09-20 | 88 | 0 |
| K231095 | Tamper Evident Cap | International Medical Industries, Inc. | 2024-09-04 | 505 | 0 |
| K240961 | Disposable Pen Injector Assembly | Wuxi Nest Biotechnology Co., Ltd. | 2024-08-15 | 129 | 0 |
| K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | Prosidyan, Inc. | 2024-07-10 | 51 | 0 |
| K233368 | Allograft Delivery Device (OFAC-C) | Bioventus, LLC | 2024-06-25 | 267 | 0 |
| K240774 | Pen Injector | Wuxi Nest Biotechnology Co., Ltd. | 2024-06-18 | 89 | 0 |
| K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with | Perfect Medical Industry (Vn) Co., Ltd. | 2024-06-12 | 266 | 0 |
| K234024 | HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2024-03-19 | 90 | 0 |
| K233794 | Insulin Syringe | Spm Medicare Pvt. , Ltd. | 2024-03-06 | 99 | 0 |
| K230235 | Medline Luer Lock Syringes | Medline Industries, LP | 2024-02-16 | 385 | 0 |
| K231558 | SMB Luer lock disposable syringe | Smb Corporation of India | 2024-01-12 | 227 | 0 |
| K231877 | NavaClick Injection System | Lineage Biomedical, Inc. | 2023-11-30 | 157 | 1 |
| K230061 | Insulin Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-11-30 | 325 | 0 |
| K231519 | Revital Cady | Revital Healthcare (Epz) Limited | 2023-11-06 | 165 | 0 |
| K233056 | EpiZact | Guidestar Medical Devices | 2023-11-02 | 38 | 0 |
| K221777 | Disposable Sterile Syringe | Weihai Shengjie Medical Technology Co., Ltd. | 2023-10-06 | 472 | 0 |
| K231792 | VeriSafe Safety sterile syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2023-09-28 | 100 | 0 |
| K231888 | BD Texium™ Needle-Free Syringe | Care Fusion | 2023-09-25 | 90 | 0 |
| K231727 | Sterile Auto-Disable Syringes with/without Needle for Single | Wepon Medical Technology Co., Ltd. | 2023-09-08 | 87 | 0 |
| K231900 | A-TAP (previously called Arthrotap) | Elcam Medical Acal | 2023-07-25 | 27 | 0 |
| K222925 | Hypodermic Syringes & Needle | Lifelong Meditech Private Limited | 2023-07-18 | 295 | 0 |
| K231456 | Avitus® DragonWing Large Volume Autograft Delivery System | Avitus Orthopaedics, Inc. | 2023-07-17 | 59 | 0 |
| K230492 | Avitus® Precision Autograft Delivery System | Avitus Orthopaedics, Inc. | 2023-06-26 | 123 | 0 |
| K212857 | Sterile Syringe for Single Use (with Needle), Sterile Hypode | Jiangsu Zhiyu Medical Instrument Co, Ltd. | 2023-05-09 | 608 | 0 |
| K220713 | Sol-Guard Auto-disable Syringe | Sol-Millennium Medical, Inc. | 2023-05-04 | 419 | 0 |
| K221974 | EpiFinder | Omeq Medical , Ltd. | 2023-04-16 | 285 | 0 |
| K212207 | Sterile Hypodermic Syringe for Single Use | Shandong Weigao Group Medical Polymer Co., Ltd. | 2023-03-23 | 616 | 0 |
| K222672 | Disposable Insulin Syringe | Hantech Medical Device Co., Ltd. | 2023-03-06 | 181 | 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