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 |
|---|---|---|---|---|---|
| K950532 | Trophy Radiologie Rvg Portable Radiovisiography | Trophy Radiologie | EAP | Class II | |
| K950425 | Tecothane 55D | Medtronic, Inc. | GZF | Class II | |
| K950341 | Barnard & Associates Remanufactured General Purpose, Vacuum or Laboratory Sterilizer | Barnard and Assoc. | FLE | Class II | |
| K945612 | Mic Nasogastric-Gastrojejunal Feeding Tube | Medical Innovations, Inc. | KNT | Class II | |
| K943257 | Tip Deflector (Genesis) | Electro-Catheter Corp. | DRF | Class II | |
| K941743 | Cabot Medical Niagara Fluid Management Pump | Cabot Medical Corp. | HIG | Class II | |
| K933512 | Upscan | Merlin Engineering Works, Inc. | KPR | Class II | |
| K933451 | Open Tip Multi-Electrode Catheter, Modification | Electro-Catheter Corp. | DRF | Class II | |
| K933450 | Closed Tip Multi-Electrode Catheter, Modification | Electro-Catheter Corp. | DRF | Class II | |
| K930564 | Holter for Windows | North East Monitoring, Inc. | DQK | Class II | |
| K951499 | Dermagran Hydrophilic Ointment | Derma Sciences, Inc. | KMF | Class I | |
| K951439 | Sunglasses | Long Train Enterprise Co., Ltd. | HQY | Class I | |
| K951423 | Aspirator, Continuous & Programmable Intermittent | ZOLL Medical Corporation | BTA | Class II | |
| K951301 | Depuy Duraloc Cementless Acetabular Cup System | Depuy, Inc. | LPH | Class II | |
| K951298 | Maxigold Kf | Ivoclar North America, Inc. | EJT | Class II | |
| K951297 | Harmony Line Kf | Ivoclar North America, Inc. | EJT | Class II | |
| K951236 | Pro-Lock | Health-Dent Intl., Inc. | DYH | Class II | |
| K951215 | Lasersonics Ultraline III Sterile Disposable Fiber | Heraeus Surgical, Inc. | GEX | Class II | |
| K950827 | Proform Porous Acetabular Assembly | Globus Medical, Inc. | LPH | Class II | |
| K950819 | Slt Sidefiring Refractive Fiber (High Power Density Fiber) | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K950776 | Bipolar Snare | Cook Incorporated | GAE | Class I | |
| K950726 | Tsi Willen-Reich Needle | Tahoe Surgical Instruments P.R., Inc. | GCJ | Class II | |
| K950301 | Angiocath(r) Nonvalon(r) and Angio-Set(r) IV Catheters | Becton Dickinson Vascular Access, Inc. | FOZ | Class II | |
| K950295 | Wound Closure/laceration Tray | Customed, Inc | LRO | Class II | |
| K950175 | The Aqua-Air Professional Field Unit(s) | Aqua-Air Medical Devices, Inc. | EIA | Class I | |
| K946201 | Stand, Infusion | Medical Specialties Inc. | FOX | Class I | |
| K946135 | Infinitech Aspirating Laser Probe | Surgical Technologies, Inc. | HQE | Class II | |
| K942142 | Frindley Enterprise Co | Frindley Enterprise Co., Ltd. | HQY | Class I | |
| K940725 | None-Generic | Yon'S Jay Enterprise Co. | HQY | Class I | |
| K940486 | Digene Dcr-1 Luminometer | Digene Diagnostics, Inc. | JJQ | Class I | |
| K934874 | Sterigage Eo 100% | Pymah Corp. | JOJ | Class II | |
| K934262 | Hprh Hospital Patient Radiant Heater | Marley Electric Heating Co. | ILO | Class II | |
| K926551 | Behring Fibrintimer a | Behring Diagnostics, Inc. | JPA | Class II | |
| K951560 | Radius Manual Whwwlchairs (Cobra, Viper, Swing, Olympia, and Mobil Models) | Radius Intl., Inc. | IOR | Class I | |
| K951263 | Intraarc Drive System | Linvatec Corporation | ERL | Class II | |
| K951207 | Varelisa Histone Antibodies | Elias U.S.A., Inc. | LJM | Class II | |
| K951206 | Varelisa Parietal Cell Antibodies | Elias U.S.A., Inc. | MLE | Class II | |
| K951205 | Varelisa Ana Profile | Elias U.S.A., Inc. | LJM | Class II | |
| K951186 | Varelisa Ana-4 Screen | Elias U.S.A., Inc. | LJM | Class II | |
| K951055 | Olympus Iga Immunoturbidimetric Reagent | OLYMPUS Corporation of the Americas | CFQ | Class II | |
| K951050 | Speculum, ENT (S3) | Pedia Pals, Inc. | ERA | Class I | |
| K951049 | Speculum, ENT (S3) | Pedia Pals, Inc. | ERA | Class I | |
| K951013 | Olympus Igg Immunoturbidimetric Reagent | OLYMPUS Corporation of the Americas | CFQ | Class II | |
| K951012 | N/t Protein Control Py | Behring Diagnostics, Inc. | GIL | Class II | |
| K950404 | Lockett Medical Corp. Gauze | Lockett Medical Corp. | EFQ | Unclassified | |
| K950373 | Ultracell Orthopedic Sponges | Ultracell Medical Technologies, Inc. | GDY | Class I | |
| K950372 | Ultracell Orthopedic Sponges | Ultracell Medical Technologies, Inc. | GDY | Class I | |
| K950370 | Ultracell Orthopedic Sponges | Ultracell Medical Technologies, Inc. | GDY | Class I | |
| K946272 | Scimed(r) Courier Guide Catheter | Scimed Peripheral Interventions | DQY | Class II | |
| K944349 | Oxylator Em-100 | CPR Medical Devices Inc. | BTL | Class II |