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 |
|---|---|---|---|---|---|
| K050455 | Synthetic Powedered Vinyl Examination Gloves | Zibo Blue Intco Plastic & Rubber Products Co., Ltd. | LYZ | Class I | |
| K050416 | Ossaplast Ortho | Ossacur AG | MQV | Class II | |
| K050345 | Cie Foldaway Wheelchair | Carlsbad International Export, Inc. | IOR | Class I | |
| K050341 | Implant Location Software, Model 0.1.0 | Tactile Technologies, Ltd. | LLZ | Class II | |
| K050328 | Pregnancy-Skreen | Biochemical Diagnostic, Inc. | JJX | Class I | |
| K050043 | Microscan Dried Gram-Positive Mic/combo Panels with Erythromycin | Siemens Healthcare Diagnostics Inc. | LRG | Class II | |
| K043600 | Medtronic Micromed 407C Infusion Pump, Model Mmt-407C | Medtronic, Inc. | FRN | Class II | |
| K042384 | Neuroport Recording Microelectrode Array System | Cyberkinetics, Inc. (Cki) | GZL | Class II | |
| K050623 | Volk Disposable Vitrectomy Lenses, Models Volk Flat Ssv D, Volk Afx Ssv D, Volk 45 Prism Ssv D | Volk Optical Inc | HJK | Class II | |
| K050552 | Pachpen Pachymeter, Model 24-5100 | Accutome, Inc. | IYO | Class II | |
| K050213 | Freshlook One-Day Color Contact Lens | Alcon Laboratories | MVN | Class II | |
| K043556 | Synchron Systems Benzodiazepine (Bnzg) Reagent | Siemens Healthcare Diagnostics Inc. | JXM | Class II | |
| K042626 | Neuroport Neural Signal Processor (Nsp) System | Cyberkinetics, Inc. | GWQ | Class II | |
| K050697 | Model Ds-1901 Digital Blood Pressure Monitor | Nihon Seimitsu Sokki Co., Ltd. | DXN | Class II | |
| K050626 | Ge Datex-Ohmeda Aespire 7900 Anesthesia System | GE Healthcare | BSZ | Class II | |
| K050597 | Ge Datex-Ohmeda Engstrom Carestation | GE Healthcare | CBK | Class II | |
| K050514 | Models Fac-63 and Fac-127 Foot and Ankle Coils | Mri Devices Corp. | MOS | Class II | |
| K050509 | Lso Pet/ct Hirez Series, Models 2I, 6I, 16I, 64I | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K050504 | Validate Urine Chemistry Calibration Verification Test Sets | Maine Standards Co. | JJY | Class I | |
| K050497 | Bioscrew Xtralok, 8X35mm & 8X40mm Violet | Linvatec Corporation | HWC | Class II | |
| K050476 | Cordless Coil | Siemens Medical Solution, Inc. USA | MOS | Class II | |
| K050372 | Visitrak, Version 1, Release 1 | Math Resolutions, LLC | IYE | Class II | |
| K050309 | Pulmanex Disposable Pressure Manometer, Model 50-5000 | Viasys Medsystems | CAP | Class II | |
| K050295 | Press Tack/intradermal Acupuncture Needles | Helio Medical Supplies, Inc. | MQX | Class II | |
| K050190 | Apollo | Villa Sistemi Medicali S.p.A. | KXJ | Class II | |
| K050070 | K-Laser, Models 3,4,4D,6d | Eltech S.R.L | ILY | Class II | |
| K050039 | Ms-930 Mars Inflate-Read Blood Pressure Monitor | Mars Medical Products | DXN | Class II | |
| K050028 | Maestro Carpal Hemiarthroplasty | Biomet Manufacturing Corp | KWN | Class II | |
| K043590 | Se Infusion System with Mms | Cardinal Health, Alaris Products | FRN | Class II | |
| K043392 | Reprocessed Electrophysiology Catheters | Alliance Medical Corp. | NLH | Class II | |
| K043183 | Epi-K | Moria SA | HNO | Class I | |
| K042091 | Biolox Delta Ceramic Heads | Zimmer GmbH | LZO | Class II | |
| K041881 | Advance Micro-Draw Blood Glucose Monitoring System, Model 411100 | Arkray Factory USA, Inc. | CGA | Class II | |
| K040419 | Dynagraft II | IsoTis OrthoBiologics, Inc. | MQV | Class II | |
| K050579 | Mega Power Electrosurgical Generator | Megadyne Medical Products, Inc | GEI | Class II | |
| K050536 | Quest Diagnostics Immunoassay/tdm Control | Bio-Rad | JJY | Class I | |
| K050479 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | IYE | Class II | |
| K050451 | Synthes Vectra System | Synthes Spine Co.Lp | KWQ | Class II | |
| K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model Bw-12 | Ceremed, Inc. | MTJ | Unclassified | |
| K050439 | Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K050331 | Adhesive 1 | Southern Dental Industries, Inc. | KLE | Class II | |
| K050301 | Mridium 3850 MRI Pump System | Iradimed Corporation | FRN | Class II | |
| K050272 | Cryomedical Instruments Cryo-Pac Systems | Cryomedical Instruments, Ltd. | GXH | Class II | |
| K050163 | Henke Sass Wolf of America Bariatric Laparoscope | Henke Sass Wolf of America, Inc. | GCJ | Class II | |
| K043613 | Q-Switched Nd:yag Ophtalmic Laser (with Slit Lamp), Model Optimis II | Quantel Medical | HQF | Class II | |
| K043580 | Alligator Retrieval Device (Ard) | Chestnut Medical Technologies, Inc. | DQY | Class II | |
| K043521 | Biosyag 50 Med | Bios S.r.l. | GEX | Class II | |
| K043454 | Cardiopal Ai with Diogenes Sv (Cardiopal Sv), Model Pm410 | Medicomp, Inc. | MLO | Class II | |
| K043063 | Oxyband Wound Dressing | Oxyband Technologies, Inc. | NAD | Class I | |
| K041715 | Intracavitary Mould Applicator Set, Model 189.001 | Nucletron BV | JAQ | Class II |