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 |
|---|---|---|---|---|---|
| K043548 | Blackstone Unity Anterior Lumbar Plate Fixation System | Blackstone Medical, Inc. | KWQ | Class II | |
| K051402 | Onepass Nuclear Medicine Imaging System | Gvi Technology Partners | IYX | Class I | |
| K051321 | Inview | Metrika, Inc. | LCP | Class II | |
| K051307 | Synchron Systems Bebzodiazapine (Ebnz) Reagent | Siemens Healthcare Diagnostics Inc. | JXM | Class II | |
| K051265 | Advia Immuno Modular System (Ims) B-Type Natriuretic Peptide (Bnp) Assay | Medrad, Inc. | NBC | Class II | |
| K051084 | Denver Pleurx Drainage Kit and Denver Pleurx Vacuum Bottle with Drainage Line | Denver Biomedicals, Inc. | DWM | Class II | |
| K050964 | Pv 1900 Synchro 0.016 Guidewire | Boston Scientific - Precision Vascular | DQX | Class II | |
| K050733 | Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls | Lin-Zhi International Inc | DJG | Class II | |
| K050727 | Modification to Nxstage Cartridge Express | NxStage Medical Inc | KDI | Class II | |
| K050673 | Candela Family of Pulse Dye Laser Systems | Candela Corporation | GEX | Class II | |
| K050662 | Quanta Lite Sp100 Elisa | Inova Diagnostics, Inc. | NUM | Class II | |
| K050649 | Silverseal Contacting Wound Dressing with X-Static | Noble Fiber Technologies, Inc. | FRO | Unclassified | |
| K050459 | Atricure Isolator Transpolar Pen | AtriCure, Inc. | OCL | Class II | |
| K050072 | Goodknight 425St | Medtronic, Inc. | BZD | Class II | |
| K043031 | Serim Dialysate Monitor Test Strip | Serim Research Corp. | NTZ | Class II | |
| K051387 | Levo Comfort II | Levo AG | IPL | Class II | |
| K051303 | Bio-Console, Model 560 | Medtronic Perfusion Systems | DWA | Class II | |
| K051228 | Biozdx Hemodynamic Monitor and 12-Lead ECG | Cardiodynamics International Corp. | DSB | Class II | |
| K051225 | Ekos Micro-Infusion System | Ekos Corp. | NUI | Class II | |
| K051190 | Xenform Soft Tissue Repair Matrix | Integra LifeSciences Braintree Inc. | PAJ | Class II | |
| K050871 | Riva Protect | Southern Dental Industries, Inc. | EBC | Class II | |
| K033720 | Ari Cold Spray | Ari | MLY | Unclassified | |
| K051250 | Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor | TORNIER Inc. | MAI | Class II | |
| K051218 | Modification to: Unicap Specific Ige | Pharmacia Diagnostics, Inc. | DHB | Class II | |
| K051105 | Basis Vertebral Body Spacer | Medtronic Sofamor Danek | MQP | Class II | |
| K050767 | Sterling Interference Screw St | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | HWC | Class II | |
| K050603 | Olpur Dialyzer, Model Hd 190 | Nephros Inc | KDI | Class II | |
| K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | NUV | Class II | |
| K050114 | Supercath Z3v | Togo Medikit Co., Ltd. | FOZ | Class II | |
| K042415 | Mendec Spine | Tecres SpA | NDN | Class II | |
| K042164 | Silver Antimicrobial Wound Gauze (Sponge) | MEDLINE INDUSTRIES, LP - Northfield | FRO | Unclassified | |
| K051470 | Remote Care Management Systems (Rcms) | Bl Healthcare, Inc. | DRG | Class II | |
| K051351 | Precedence Spect/ct Imaging System | Philips North America LLC | KPS | Class II | |
| K051235 | On Trak Testcard | Varian, Inc. | DKZ | Class II | |
| K051189 | Prevail Dental Implants | ZimVie US Corp LLC | DZE | Class II | |
| K051187 | Rexeed Series Dialyzers | Asahi Kasei Medical Co., Ltd. | KDI | Class II | |
| K051179 | Ez Plus Retrieval Sheath, Model 38899-150 | Boston Scientific Corporation | NFA | Class II | |
| K051125 | Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677 | Abbott Medical | FZP | Class II | |
| K051029 | Stelthstation Wireless Surgeon Mouse | Medtronic Surgical Navigation | HAW | Class II | |
| K050916 | Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral] | Intra Luminal Therapeutics, Inc. | PDU | Class II | |
| K050878 | On Call Multi-Drug Home Test Cup | Acon Laboratories, Inc. | LDJ | Class II | |
| K050406 | Nobelspeedy Implants | Nobel Biocare AB | DZE | Class II | |
| K050273 | Fresenius Art Hemoadsorption System | Fresenius Medical Care Renal Therapies Group, LLC | LKN | Unclassified | |
| K043480 | Enhance Clitoral Stimulation Aid | Gynavations, Inc. | NBV | Class II | |
| K043408 | Piezosurgery Device | Piezosurgery S.r.l. | DZI | Class II | |
| K051347 | Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove | Kimberly-Clark Corporation | LZA | Class I | |
| K051166 | Powder Free Vinyl Synthetic Examination Gloves with Plasticizer Ebn&bet | Gloveco, Inc. | LYZ | Class I | |
| K051103 | Haag-Streit Contact Glasses Stery Cup, Accessory | Haag-Streit USA Inc | HJK | Class II | |
| K051006 | Ibond Next Generation | Kulzer GmbH | KLE | Class II | |
| K050915 | Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary] | Intra Luminal Therapeutics, Inc. | DQX | Class II |