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 |
|---|---|---|---|---|---|
| K992529 | Tissue Spectroscope | Vital Medical, Ltd. | DPW | Class II | |
| K003408 | CT Cord Iq Option 1.0 | GE Healthcare | JAK | Class II | |
| K003335 | Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer | Hill-Rom Air-Shields | FMT | Class II | |
| K003132 | Dermagrip Powder Free Blue Polymer Coated Latex Examination Glove, Non-Sterile Contains 50 Microgram or Less of Total Wa | Wrp Specialty Products Sdn. Bhd. | LYY | Class I | |
| K003007 | Galaxy | Sterngold | EJT | Class II | |
| K002840 | Marks Reference Phantom, Measure Reference Phantom | Phantom Laboratory | IZI | Class II | |
| K002786 | Biosensors Central Venous Catheter Kits | Sunscope Intl., Inc. | FOZ | Class II | |
| K002780 | Viatronix Visualization System (Vvs) | Viatronix, Inc. | LLZ | Class II | |
| K002724 | Numalink | Numa, Inc. | LLZ | Class II | |
| K002709 | Race Endodontic File | Amc General, Inc. | EFA | Class I | |
| K002692 | Defender Room Air Cleaner, Model Rac-3000A | Hmi Industries, Inc. | FRF | Class II | |
| K002597 | Cn Acquisition Station | Cardionow, Inc. | LLZ | Class II | |
| K002595 | Cbs Straw | Cryo Bio System | MQG | Class II | |
| K002586 | Medpor Pterional Surgical Implant | Porex Surgical Products Group | MNF | Class II | |
| K001544 | Vaginal Applicator Shielded | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | |
| K003434 | Allegro Tb, Allegro N | Philips North America LLC | KPS | Class II | |
| K003399 | Sonosite Hand-Carried Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K003261 | Creatinine Plus | Roche Diagnostics GmbH | JFY | Class II | |
| K002993 | Heraceram | J.F. Jelenko & Co., Inc. | EIH | Class II | |
| K002935 | Synthes 1.5Mm Ti Brow Lift Screw | Synthes (USA) Products LLC | DZL | Class II | |
| K002859 | Ssw-Sterile Solution Warmer | Kmi Kolster Methods, Inc. | LHC | Class I | |
| K002774 | Hrh-63 Head Array Coil | Mri Devices Corp. | MOS | Class II | |
| K002620 | Suresmile System | OraMetrix GmbH | EIA | Class I | |
| K002619 | Newgen System | Stryker Corp. | JEY | Class II | |
| K002608 | Invac | Duncan Hynd Associates, Ltd. | IYE | Class II | |
| K002584 | Ecat Accel Pet Scanner | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K002573 | Advanced Uroscience Innersheath | Advanced Uroscience, Inc. | FBK | Class II | |
| K002572 | Medtronic Ps Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 | Medtronic PS Medical | GWG | Class II | |
| K002571 | Mulitple Male Latx Condom | Pleasure Latex Products Sdn. Bhd. | HIS | Class II | |
| K002447 | Modification to Rapid Drug Screen 9-Panel | American Bio Medica Corp. | DKZ | Class II | |
| K002080 | Behring Coagulation System, Model Bcs | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K001663 | Front-Load Polypropylene Syringe | Medrad, Inc. | DXT | Class II | |
| K000253 | Silent Night V | Sleep Solutions, Inc. | MNR | Class II | |
| K003153 | Solobond Plus | Voco GmbH | KLE | Class II | |
| K002843 | Sultan Sensitemp Resin Temporary Cement, Model 70010 | Sultan Chemists, Inc. | EMA | Class II | |
| K002600 | Litwin Cruicate Anchor | Instrument Makar, Inc. | MBI | Class II | |
| K002575 | Inter-Op Durasul Acetabular Inserts (4Mm) | Sulzer Orthopedics, Inc. | LWJ | Class II | |
| K001841 | 35/Cd Cineconverter | Tagarno A/S | LMA | Class II | |
| K001685 | Psn Hemodialyzer, Model Psn 130, 150, 170, 210 | Baxter Healthcare Corporation | MSE | Class II | |
| K003308 | Microlife Digital Infrared Ear Thermometer, Ir1dai, Ir1db1, Ir1dd1 | Microlife Corp. | FLL | Class II | |
| K002530 | Welch Allyn Spot Check Device | Welch Allyn Inc | DXN | Class II | |
| K000654 | Vbmax | A-M Systems | CAH | Class II | |
| K003349 | Allon 2001 Modified | Mtre Advanced Technology, Ltd. | DWJ | Class II | |
| K002680 | Tissuelink Monopolar Floating Ball' | Medtronic Navigation, Inc | GEI | Class II | |
| K002677 | Nuvasive Ins-1 Intraoperative Nerve Surveillance System | NuVasive Inc | BXM | Class II | |
| K002615 | Surgical System with Cryoguide | Varian Medical Systems, Inc. | GEH | Class II | |
| K002552 | Howmedica Osteonics Modular Rotating Hinge Knee | Howmedica Osteonics Corp | KRO | Class II | |
| K002521 | Spartan Mts | Spartan Marketing Group | ELC | Class II | |
| K002520 | Rovers Spatula | Rovers Medical Devices B.V. | HHT | Class II | |
| K002059 | Amt Spinal System | Micron Precision Engineering, Inc. | KWP | Class II |