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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K905206 | Incare Pinsite Dressing | Hollister, Inc. | KOZ | Class I | |
| K905065 | Defibrillator Lead Adapter | Spacelabs, Inc. | LDD | Class II | |
| K905060 | Electrode Extender | Megadyne Medical Products, Inc | JOS | Class II | |
| K904984 | Advance 418(Tm) | Peripheral Systems Group | LIT | Class II | |
| K904752 | Chemstrip(r) Micral(tm) Urine Test Strips | Boehringer Mannheim Corp. | JIR | Class I | |
| K904705 | Bc 1206 Implant - Insert Type | Minimatic Implant Technology | DZE | Class II | |
| K904618 | Cvis Insight Imaging Catheter | Cardiovascular Imaging Systems, Inc. | DQO | Class II | |
| K903061 | Utak Laboratories Toxicology Control | Utak Laboratories Inc | LAS | Class I | |
| K910707 | Operaid Surgical Drain W/ Corneal Shields | JEDMED Instrument Company | HOZ | Class II | |
| K910179 | Optical Frame | Australian Optical Co., Inc. | HQZ | Class I | |
| K910124 | Low Vision Enhancement System (Lves) | Triangle Investments | HPG | Class I | |
| K910107 | Duraflo II Heparin Oxygenator Model Univox Gold | Baxter Healthcare Corporation | DTZ | Class II | |
| K905634 | Smt-50X | Shimadzu Medical Systems | LNH | Class II | |
| K905373 | Miniature Temperature Trainer Model Dt-002 | Bio-Feedback Systems, Inc. | HCC | Class II | |
| K905225 | Hbo Cable Assembly, Radiometer Tc-02 | Sechrist | LKD | Class II | |
| K904830 | Bacteria Filter | Vital Signs, Inc. | CAH | Class II | |
| K904763 | Mentor EEG System | Oxford Medilog, Inc. | GWQ | Class II | |
| K903020 | Respiration/heart Rate Monitor Model 9500/9550 | Aequitron Medical, Inc. | BZQ | Class II | |
| K900557 | Modified Aerochamber M.v. Aerosol Holding Chamber | Monaghan Medical Corp. | CCQ | Class I | |
| K911203 | Tegwire (Tm) | Boston Scientific Corporation | LIT | Class II | |
| K910996 | Opti-Plast 5F Pta Catheters | Vas-Cath, Inc. | LIT | Class II | |
| K910995 | Medi-Tech Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K910923 | Bcd Advanced | Shiley, Inc. | DTR | Class II | |
| K910718 | Ysi Precision 4000 Thermometer | Yellow Springs Instrument Co., Inc. | FLL | Class II | |
| K910568 | Model 5866-46 Sleeve Kit | Medtronic, Inc. | DTP | Class II | |
| K910548 | Feldmuehle Ceramic Head (12/14 X 32Mm) | Turnkey Intergration USA, Inc. | LZO | Class II | |
| K910526 | Microtest Multi Microbe Medium | Microtest | JSM | Class I | |
| K910236 | Renaflo Hdf 1350 Hemodiafilter | Medivators Inc | KDI | Class II | |
| K910215 | Drake Willock System 1000 Dialysate Delivery Syst | Cd Medical, Inc. | FKP | Class II | |
| K910154 | Usci Illumen-8 8F Ptca Guiding Catheter | C.R. Bard Inc | DOY | Class II | |
| K910114 | Optilite (Tm) Fiberoptic Delivery Systems and Acce | Xintec Corporation | GEX | Class II | |
| K905516 | Model Ft40 Transonic(tm) Hearing Aid | Sonovation, Inc. dba Avr Sonovation | ESD | Class I | |
| K905505 | Vas-Cath Ureteral Stents Catheter, Modification | Vas-Cath, Inc. | FAD | Class II | |
| K905487 | Various Types of Stethoscopes | Liaoning-Usa Corp. | LDE | Class I | |
| K905288 | Anesthesia/respiratory Face Mask, Various Sizes | Med-Tek Innovations, Inc. | BYG | Class I | |
| K905217 | Formasure Test Reagent | Di-Chem, Inc. | LIF | Class II | |
| K905102 | Bard(r) Syringe Assist Irrigation | C.R. Bard Inc | OCX | Class II | |
| K904946 | Haemodialysis Concentrate | Bdh, Inc. | KPO | Class II | |
| K904843 | Oscar(tm) II Capnometer & Pulse Oximeter | Dalton Instrument Corp. | CBR | Class II | |
| K911299 | Equipment/material Decontaminating Kit | Rohm and Haas Co. | KIE | Class I | |
| K910683 | Enzymun-Test Progesterone | Boehringer Mannheim Corp. | JLS | Class I | |
| K910534 | Synchron Lactate Reagent | Beckman Instruments, Inc. | KHP | Class I | |
| K910461 | Osteonics(r) Mid-Shaft Cement Spacer | Osteonics Corp. | JDK | Class II | |
| K910428 | Epidural Indication for Volumetric Infusion Pumps | Baxter Healthcare Corporation | FRN | Class II | |
| K910362 | Tracheostomy Care Kit | Megadyne Medical Products, Inc | JOH | Class II | |
| K910269 | 10 Adjustable Belt Coil | Resonex, Inc. | LNH | Class II | |
| K910219 | Laparomed Cholangiogram Device | Laparomed Corp. | FGE | Class II | |
| K910218 | Laparomed Cholangiogram Vacuum Device | Laparomed Corp. | GCX | Class II | |
| K910137 | Plp Laparoscopic Cholecystectomy Set | Precision Laser Products, Inc. | GEX | Class II | |
| K910092 | 3M Laser Imager Xl | 3M Medical Products Group | LMC | Class II |