Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FPA — Predicate Candidate Screening
1,174 FDA 510(k) clearances under this product code; the 50 most recent screened below.
79 daysmedian FDA review time
268 days90th percentile
1,174clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261530 | iiSure Infusion Set | Deka Research and Development | 2026-06-03 | 26 | 0 |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, B | Amsino International, Inc. | 2026-05-04 | 265 | 0 |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | 2026-02-12 | 286 | 0 |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set w | Np Medical | 2025-12-04 | 225 | 0 |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | 2025-10-30 | 267 | 0 |
| K251814 | EZ™ IV Administration Set | Epic Medical Pte. , Ltd. | 2025-08-29 | 77 | 0 |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | 2025-08-06 | 50 | 0 |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | 2025-08-01 | 231 | 0 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Set | B.Braun Medical, Inc. | 2025-07-24 | 266 | 0 |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | 2025-06-05 | 97 | 0 |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025-05-09 | 242 | 0 |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | 2025-05-02 | 232 | 0 |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025-03-14 | 120 | 1 |
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2025-02-28 | 205 | 0 |
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. | 2024-12-18 | 244 | 0 |
| K234129 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2024-09-20 | 267 | 0 |
| K242126 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | 2024-08-22 | 34 | 1 |
| K232475 | Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2024-05-10 | 268 | 0 |
| K222766 | Disposable Extension Set | Shandong Ande Healthcare Apparatus Co., Ltd. | 2024-04-12 | 577 | 0 |
| K232328 | Insignis™ Syringe Infusion System | Innovative Health Sciences, LLC | 2024-03-01 | 211 | 0 |
| K231707 | ResQ Administration Set | Q For Plastic Industries | 2024-01-03 | 205 | 0 |
| K230528 | Extension Set | Medcaptain Life Science Co., Ltd. | 2023-12-01 | 277 | 0 |
| K222780 | LILY Extension Tube and Needleless Connector | Lily Medical Corporation | 2023-11-09 | 421 | 0 |
| K230343 | ProSeal™ Closed System Administration Set | Epic Medical Pte. , Ltd. | 2023-11-03 | 268 | 0 |
| K221327 | BD Alaris™ Pump Infusion Sets | Care Fusion | 2023-07-21 | 441 | 0 |
| K221411 | Surflo Winged Infusion Set | Terumo Medical Products (Hangzhou) Co., Ltd. | 2023-06-23 | 403 | 0 |
| K221121 | Volumat Polyethylene I.V. Administration Set | Fresenius Kabi | 2023-06-16 | 424 | 0 |
| K230992 | DJF Intravascular Administration Set | Yangzhou Wei DE LI Trade Co., Ltd. | 2023-06-09 | 64 | 0 |
| K220301 | Volumat Line | Fresenius Kabi | 2023-06-02 | 485 | 0 |
| K223645 | I.V. Administration Set, I.V. Extension Set | Bq Plus Medical Co., Ltd. | 2023-05-18 | 163 | 0 |
| K223101 | BD Secondary Infusion Set | Care Fusion | 2023-05-12 | 224 | 0 |
| K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Conn | Np Medical, Inc. | 2023-04-19 | 442 | 0 |
| K220312 | Polyfusion IV Administration Sets | Poly Medicure Limited | 2023-04-12 | 434 | 0 |
| K223088 | BD SmartSite™ Needle-Free Connector | Care Fusion | 2023-04-07 | 189 | 0 |
| K222889 | FlowArt® Needle-Free Split Septum Valve | Asset Medikal Tasarim San Tic As. | 2023-01-20 | 119 | 0 |
| K221069 | Infusion Sets for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 | 223 | 0 |
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needle | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 | 223 | 0 |
| K221075 | Infusion Sets for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 | 223 | 0 |
| K221518 | NP Medical nCompass Extension Set with Stabilizing Base | Np Medical | 2022-11-03 | 162 | 0 |
| K220267 | AMSafe NeuFlo Needleless Connector | Amsino International, Inc. | 2022-10-07 | 249 | 0 |
| K212262 | PCA Syringe Sets | Baxter Healthcare Corporation | 2022-10-03 | 440 | 0 |
| K221473 | Flowart | Asset Medikal Tasarim As. | 2022-09-26 | 129 | 0 |
| K221481 | NeutrArt | Asset Medikal Tasarim As. | 2022-09-23 | 123 | 0 |
| K213846 | Q2 Blood Administration Sets | Quest Medical, Inc. | 2022-06-05 | 177 | 0 |
| K213588 | Q2 IV Administration Sets | Quest Medical, Inc. | 2022-06-02 | 202 | 0 |
| K213004 | Needle Free Connector | Medcaptain Life Science Co., Ltd. | 2022-05-10 | 232 | 0 |
| K202437 | Infusion Sets for Single Use | Jiangsu Suyun Medical Materials Co., Ltd. | 2022-03-25 | 577 | 0 |
| K213778 | IV Administration Set | B.Braun Medical, Inc. | 2022-03-03 | 90 | 0 |
| K212842 | Microvolume Luer Access Device | B.Braun Medical, Inc. | 2022-01-18 | 133 | 0 |
| K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit | Ivenix, Inc. | 2021-11-10 | 47 | 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