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 |
|---|---|---|---|---|---|
| K020945 | Axsym Intact Pth, Model 2G06 | Diagnostic Systems Laboratories, Inc. | CEW | Class II | |
| K020802 | Renut Multiplus Mullti-Purpose Solution | Bausch & Lomb Incorporated | LYL | Class II | |
| K020033 | Maxistat Pva Foam Embolization Particles | Surgica Corp. | HCG | Class II | |
| K013712 | Enteryx Injector | Enteric Medical Technologies | FBK | Class II | |
| K013258 | Inpath E2 Collector | Molecular Diagnostics | HHT | Class II | |
| K021614 | Digital Clinical Thermometer, Model Act 3020 | Actherm, Inc. | FLL | Class II | |
| K021612 | Digital Clinical Thermometer, Models Act 2030, 2038 | Actherm, Inc. | FLL | Class II | |
| K021589 | Attain Access 6218A Left-Heart Delivery System, Model 6218 | Medtronic, Inc. | DQY | Class II | |
| K021587 | Attain Lds 6216A Left-Heart Delivery System, Model 6216A | Medtronic, Inc. | DQY | Class II | |
| K021374 | Toesco Aqua Blue LED Light Curing Device | Toei Electric Co., Ltd. | EBZ | Class II | |
| K021364 | Modification to Entec Plasma Wands | ArthroCare Corporation | GEI | Class II | |
| K021208 | Immulite 2000 Mixed Allergen Panels | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K021206 | Immulite 2000 Specific Allergens | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K020952 | Surx RF System | Surx, Inc. | MUK | Class II | |
| K020732 | Ss Matrix | Cook Biotech, Inc. | KGN | Unclassified | |
| K020673 | Wave Form Manufacturing Prolase General Shaped Fiber | Wave Form Mfg., Inc. | GEX | Class II | |
| K013646 | Rose K Post Graft Lens | Rose K International, Ltd. | HQD | Class II | |
| K013021 | Lightlance Laser Skin Perforator | Innotech USA, Inc. | GEX | Class II | |
| K021577 | Modification to En-Bloc Biopsy System | Neothermia Corp. | GEI | Class II | |
| K021439 | Model R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle, and Serial Interface Adaptor Do | Animas Corp. | LZG | Class II | |
| K021415 | Liquichek Urine Toxicology Control Level C2 Low Opiate & C3 Low Opiate Models 468 & 469 | Bio-Rad | DIF | Class I | |
| K021414 | Liquichek Urine Toxicology Control Level S1 Low Opiate & S2 Low Opiate Models 466 & 467 | Bio-Rad | DIF | Class I | |
| K021411 | Liquichek Urine Toxicology Control Level S1, S2 & S3 Models 461, 462 & 463 | Bio-Rad | DIF | Class I | |
| K021384 | Liquichek Urine Toxicology Control Levels C1-C4, Models 441,442,443,444 | Bio-Rad | DIF | Class I | |
| K020646 | Replace Ha Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 | Nobel Biocare Uas, Inc. | DZE | Class II | |
| K013615 | Micro-Induction 1000 System | Harbinger Medical, Inc. | DPS | Class II | |
| K021380 | Oss Les Proximal Femoral Component | Zimmer GmbH | JDI | Class II | |
| K021121 | Aromacryl | Aromacryl, LLC | EBI | Class II | |
| K021118 | Detachable Monopolar EMG Needle, Models 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 | Class A Ent. | GXZ | Class II | |
| K020893 | Norad Nocturnal Oral Airway Dilator Appliance | Dennis R. Bailey, Dds | LRK | Class II | |
| K020778 | Gyrus ENT Somnoplasty Tissue Coagulating Electrode, Model 2420 | Gyrus Ent LLC | GEI | Class II | |
| K020743 | Padpro, Model 2502 | Padpro, LLC | MKJ | Class III | |
| K020699 | Tsrh Spinal System | Medtronic Sofamor Danek | MNH | Class II | |
| K020643 | Ez-Scope an & Ez-Scope an Lite | Health Policy Resorters Group, LLC | IYX | Class I | |
| K020640 | Ksea Scb Media Control | Karl Storz Endoscopy-America, Inc. | FTA | Class II | |
| K020637 | Select Stim | Care Rehab and Orthopaedic | IPF | Class II | |
| K013687 | Nose Breathe Mouthpiece for Heavy Snorer | Steven K. Sue | LRK | Class II | |
| K011461 | Access Cardiosystems Manual Defibrillator | Access Cardiosystems, Inc. | LDD | Class II | |
| K021498 | Liquichek Cardiac Markers Control Lt Level 1, 2, 3, and Trilevel | Bio-Rad | JJT | Class I | |
| K021409 | At Home Ovulation Test, Model 9032 | Phamatech Inc. | CEP | Class I | |
| K021344 | B-F200 Bronchoscope with Bss-F21 Endosheath System | Cogentix Medical, Inc. | EOQ | Class II | |
| K020962 | G4 Sleeved Nail | Biomet Manufacturing Corp | HSB | Class II | |
| K020950 | Spectral's 2 in 1 (Tni-Myo) | Spectral Diagnostics, Inc. | MMI | Class II | |
| K020701 | Syncrus Internal Cardioversion System | Guidant Corporation, Cardiac Surgery | NHW | Class II | |
| K020661 | Unity Is Patient Viewer | General Electric Medical Systems Information Techn | MSX | Class II | |
| K020642 | Soft K. and Soft K. Toric (Xyloficon a) Soft (Hydrophillic) Keratoconus Contact Lens for Daily Wear | Soflex Contact Lens Industries, Ltd. | LPL | Class II | |
| K020628 | Curelle, Preferred Curelle, Cuteq 2.5 | Bioteque America Inc | HHK | Class II | |
| K020614 | Irrigating Cannula | Ca Guard, Ltd. | OCX | Class II | |
| K020315 | 14F X 55Cm Ash Split-Cath Xl, Model Aspc55-Xl | Medcomp | MSD | Class II | |
| K021324 | Fixion Intramedullary Nailing System (Fixion Im Nailing System) | Disco-O-Tech Medical Technologies, Ltd. | HSB | Class II |