510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K812533 | Platelet Agitator | Helmer Labs, Inc. | KSQ | Class I | |
| K812498 | Clirans Te12 Hollow Fiber Dialyzer | Terumo Medical Corp. | KOC | Class II | |
| K812330 | Dialysate Concentrate | Central Biological Co. | FKQ | Class II | |
| K812202 | Fiber Optic Light Source | Reznik Instruments | HIH | Class II | |
| K812200 | Insufflator | Reznik Instruments | HIF | Class II | |
| K812297 | A.d.t. Procedures Tray | A.D.T. Lab Industries | KMJ | Class I | |
| K812655 | Velcro Splint Strap Fasteners | Maddak, Inc. | ILH | Class I | |
| K812654 | Velcro Finger/toe Splint | Maddak, Inc. | ILH | Class I | |
| K812569 | Sherwood Water Trap | Sherwood Medical Co. | BYH | Class I | |
| K812568 | Cavitron | G-C Intl. Corp. | EMA | Class II | |
| K812563 | Swan-Ganz & Edslab Heparin Coated Cath. | American Edwards Laboratories | DYG | Class II | |
| K812550 | Beaucav | Sci-Pharm, Inc. | LBH | Class II | |
| K812549 | Beauseal | Sci-Pharm, Inc. | EBC | Class II | |
| K812548 | Cobeau | Sci-Pharm, Inc. | LBH | Class II | |
| K812546 | Beaudent | Sci-Pharm, Inc. | EBF | Class II | |
| K812545 | Beaufill | Sci-Pharm, Inc. | EBF | Class II | |
| K812520 | 280/4 Mini-Defibrillator | Life Science Instrumentation, Inc. | LDD | Class II | |
| K812519 | 2000 Series Portable Resuscitation Syst. | Life Science Instrumentation, Inc. | LDD | Class II | |
| K812459 | Exmoor Aural Grommet Ag/ti | Exmoor Plastics Limited | ETD | Class II | |
| K812449 | Adaptic* C.f.s. | Johnson & Johnson Professionals, Inc. | EBF | Class II | |
| K812354 | Kontron Pms 7000 | Kontron Instruments, Inc. | DQK | Class II | |
| K812326 | Sorenson Subclavian Catheter Ssc-8 | Sorensen Research | LFJ | Class II | |
| K812324 | Flow-Directed Thermodilution Catheter | Sorensen Research | DYG | Class II | |
| K812276 | Disposable Electrode, #1610 | Andover Medical, Inc. | DRX | Class II | |
| K812147 | Cardiorater Cr-7 | Life Science Instrumentation, Inc. | DRT | Class II | |
| K812146 | Cardiorater Cr-5 | Life Science Instrumentation, Inc. | DRT | Class II | |
| K812145 | Cardiorater Cr-3 | Life Science Instrumentation, Inc. | DRT | Class II | |
| K812144 | Centeral Monitor 360 | Life Science Instrumentation, Inc. | DRT | Class II | |
| K812041 | Venti-Monitor Model 101 | Medix Medical Electronics (U.S.A.), Inc. | CAP | Class II | |
| K812039 | Spirometer 210/211 | Medix Medical Electronics (U.S.A.), Inc. | BZG | Class II | |
| K812622 | Hemodialysis Venous & Arterial Set | Amisco Trading Corp. | FKH | Class II | |
| K812621 | Delta-A.v. Fistula Cannulation Set | Amisco Trading Corp. | FIE | Class II | |
| K812592 | Ultra Zyme Plus Got #64953, 65033 & 34 | Harleco | CIT | Class II | |
| K812591 | Ultra Zyme Plus Gpt, #64956, 65035 & 36 | Harleco | CKA | Class I | |
| K812590 | Ultra Zyme Plus Ldh #64950, 65038 & 39 | Harleco | CFJ | Class II | |
| K812589 | Ultra Chem E-Trig #65024 | Harleco | CDT | Class I | |
| K812583 | Bovine Chemistry Control i.x. & Ii.x. | American Dade | JJY | Class I | |
| K812574 | Hdl Cholesterol Reagent | Horiba Instruments Incorporated | LBR | Class I | |
| K812554 | Tomac Sterile Disp. Lap Sponge | American Convertors Div., American Pharmaseal | GDY | Class I | |
| K812540 | Cordia Im | Cordis US Corp. | KTN | Class II | |
| K812506 | The Arthrofile | Dyonics, Inc. | HTR | Class I | |
| K812503 | Bosch Hearing Instruments | Retlif, Inc. | CCQ | Class I | |
| K812482 | Foam Wedge | Maddak, Inc. | LDQ | ||
| K812227 | Gammacoat (125) Insulin Radioimmunoassay | Clinical Assays, Inc. | CFP | Class I | |
| K812162 | Hemodialysis Transducer Protector | Membrana | FIB | Class II | |
| K812125 | Lapin Clear Cut II | Promed Corp. | GEI | Class II | |
| K812108 | Low Fibrinogen Control | Bio/Data Corp. | KQJ | Class II | |
| K812045 | Infant Apnea Monitor Model 100 | Medix Medical Electronics (U.S.A.), Inc. | BZQ | Class II | |
| K812012 | Townley Unicondylar Knee | Depuy, Inc. | HRY | Class II | |
| K811821 | Carotid Artery Clamp & Tools | New England Surgical Instrument Corp. | HCE | Class II |