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 |
|---|---|---|---|---|---|
| K993898 | Kac-63 Knee Array Coil | Mri Devices Corp. | MOS | Class II | |
| K993834 | Surgical Lightstic, Models, 180 L, and 180 C | CardioFocus, Inc. | GEX | Class II | |
| K993785 | Ultraclip Tissue Marker | Inrad | GDW | Class II | |
| K993762 | I.co.s Screw | New Deal, S.A. | HWC | Class II | |
| K992805 | Oratec Ablator-S Probes (Monopolar Ablation Suction Probes) | Oratec Interventions, Inc. | GEI | Class II | |
| K992525 | Acumed Modular Shoulder System | Acu Med, Inc. | HSD | Class II | |
| K992012 | Wiltse System | Advanced Spine Fixation Systems, Inc. | KWQ | Class II | |
| K991580 | Ilm Endotracheal Tube | The Laryngeal Mask Co., Ltd. | BTR | Class II | |
| K991412 | Vitalograph Micro | Vitalograph, Inc. | BZH | Class II | |
| K000207 | Porocoat Prodigy Hip Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K000131 | Quickscreen Pro Multi Drug Screening Test, Model 9153 Pat04 | Phamatech Inc. | LDJ | Class II | |
| K000079 | Nikopad Electrosurgical Grounding Pad, Model 4777M | Nikomed U.S.A., Inc. | HAM | Class II | |
| K000074 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Plasma Scalpel Gs, Turbovac Gs | ArthroCare Corporation | GEI | Class II | |
| K000036 | Entec Reflex Wand 55, Model E4055-00 | ArthroCare Corporation | GEI | Class II | |
| K000015 | Barcomed 2Mp2 | Barco N.V. | LLZ | Class II | |
| K994416 | Polymer Coated Powder Free Nitrile Examination Gloves, Blue | Flexitech Sdn. Bhd. | LYY | Class I | |
| K994415 | Marathon Cross-Linked Polyethylene Acetabular Cup Liners | Depuy Orthopaedics Inc. | LPH | Class II | |
| K994338 | Autostat II Rheumatoid Factor Igm Elisa | Cogent Diagnotics, Ltd. | DHR | Class II | |
| K994268 | Arabesk Top | Voco GmbH | EBF | Class II | |
| K994256 | Suction Irrigation Trumpet Valve Set, Model Q65-823 | A & A Medical, Inc. | GCJ | Class II | |
| K994227 | Advantage Hcg Test (Urine/serum) | Advantage Diagnostics Corp. | JHI | Class II | |
| K994169 | Synchron Cx Systems Prealbumin Calibrator | Siemens Healthcare Diagnostics Inc. | JIS | Class II | |
| K994168 | Synchron Lx Systems Prealbumin Calibrator | Siemens Healthcare Diagnostics Inc. | JIS | Class II | |
| K994136 | Powder-Free Non-Sterile Vinyl Examination Gloves | Shanghai Champion Plastic Products Co., Ltd. | LYZ | Class I | |
| K994127 | Glory | Pillar Technology, Inc. | INI | Class II | |
| K994024 | Extended Straight Attachment | Team Technologies, Inc. | EGS | Class I | |
| K994006 | Avocet Acusure (for Patient Self-Testing) and Avocet Acusure Pro (for Professional Use) | Avocet Medical, Inc. | GJS | Class II | |
| K993810 | Cd Horizon Spinal System | Danek Medical, Inc. | MNH | Class II | |
| K993745 | K-Defib/pace Adult Electrode, Model Kdp-80 | Katecho LLC | MKJ | Class III | |
| K993383 | Hp Viridia Multi-Measurement Server/compact Portable Patient Monitor Models M3000a, M3046a, M3015a, Rel.b | Hewlett-Packard Co. | DSI | Class II | |
| K993051 | Versalet 7700 Care Center, Model # 7700 | Hill-Rom Air-Shields | FMZ | Class II | |
| K992828 | E-2000 Power Elevating Seat System, Models Ard-Estorm, Ard-Ep320, Ard-Elancer | Accelerated Rehab Designs, Inc. | ITI | Class II | |
| K992804 | T-2000-Power Tilt Seating System, Models Ard-Tstorm, Ard-Tp-320, Ard-Tg424, Ard-Ts525, Ard-Tjazzy, Ard-Tlancer | Accelerated Rehab Designs, Inc. | ITI | Class II | |
| K992652 | Sd-730 If-Sds, Perfect Pulse If-Sds | Skylark Device & Systems Co., Ltd. | LIH | Class II | |
| K990403 | Ted 200T7 Oxygen Monitor | Teledyne Electronic Technologies | CCL | Class II | |
| K000172 | Depuy Contour Unicompartmental Knee Prosthesis | Depuy Orthopaedics Inc. | HRY | Class II | |
| K000120 | Pro-Torq | Micro Motors, Inc. | EBW | Class I | |
| K000089 | Synthes 4.0 and 5.0 Mm Locking Screws | Synthes (USA) Products LLC | HWC | Class II | |
| K000083 | Ebi Xfix Dfs Rail System | Ebi, LLC | KTT | Class II | |
| K000020 | Modification to Isobar Spinal System | Encore Orthopedics, Inc. | MNH | Class II | |
| K994261 | Ultratemp Temporary Polycarboxylate Cement | Ultradent Products Inc. | EMA | Class II | |
| K993917 | Tokuyama One-Up-Bond F | Tokuyama America Inc. | KLE | Class II | |
| K993786 | Rusch Oral/nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/murphy | Rusch Intl. | BTR | Class II | |
| K993782 | Simplex Condoms, Latex Condoms-with Spermicidal Lubricant (Nonoxynol-9) | P.T. Vonix Latexindo Condom (Rubber) Mfg. | HIS | Class II | |
| K993781 | Simplex Condoms, Latex Condoms-Silicon Lubricated | P.T. Vonix Latexindo Condom (Rubber) Mfg. | HIS | Class II | |
| K993779 | Simplex Condoms, Latex Condoms-Flavored and Lubricated | P.T. Vonix Latexindo Condom (Rubber) Mfg. | HIS | Class II | |
| K993751 | Corometrics Model 173 Fetal Monitor | GE Medical Systems Information Technologies, Inc. | HGM | Class II | |
| K993750 | Prosolv Echoviewer, Prosolv Echoviewer Se, Prosolv Echoanalyzer, Prosolv Echoserv, Prosolv Echo | Problem Solving Concepts, Inc. | LLZ | Class II | |
| K993742 | Super Tissue | I.Z.I. Corp. | IYE | Class II | |
| K993580 | Specialty 55 (Methafilcon a) Soft (Hydrophilic) Contact Lenses for Daily Wear | Specialty Ultravision, Inc. | LPL | Class II |