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 |
|---|---|---|---|---|---|
| K961854 | Spr Plus II Overlay System (Cl250/cl212 | Gaymar Industries, Inc. | FNM | Class II | |
| K961791 | Depuy Disposable Filter/hood | Depuy, Inc. | LYU | Class I | |
| K961467 | Head Retaining Device | S. and H. Engineering, Inc. | IYE | Class II | |
| K961139 | Eagle Patient Monitor Model 3000/3100 | Marquette Electronics, Inc. | DSI | Class II | |
| K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | LXB | Class II | |
| K955563 | Foundation Forged, Textured & Porous Stems W/biolox Ceramic Heads | Encore Orthopedics, Inc. | LPH | Class II | |
| K962362 | Cordis Envoy & Vista Brite Tip Guiding Catheters | Cordis US Corp. | DQY | Class II | |
| K962346 | Papillotome | United States Endoscopy Group, Inc. | KNS | Class II | |
| K962210 | Bactec 9050 System | Becton Dickinson Diagnostic Instrument Systems | MDB | Class I | |
| K962132 | Silkon Stainless Steel Cable System | Osteonics Corp. | JDQ | Class II | |
| K962002 | Aura Hip System Calcar Replacement Femoral Stem | Exactech, Inc. | JDG | Class II | |
| K961998 | Qualitrol Syphsero Control Set | Consolidated Technologies, Inc. | GMP | Class II | |
| K961902 | Siemens Beam Shaper | Siemens Medical Solutions USA, Inc. | IXI | Class II | |
| K961752 | H/s Catheter Set(61-3005, 61-3007, 61-3605, 61-3607) | Ackrad Laboratories | LKF | Class II | |
| K961288 | Bodytrode | Marquette Electronics, Inc. | DRX | Class II | |
| K961194 | Antimicrobial Mediastinal Silicone Drain | Sil-Med Corp. | GBW | Class I | |
| K961116 | First Beat/cardio Beat/calc | Medasonics, Inc. | IYO | Class II | |
| K960908 | Srrs Pressed Fit Femoral Revision Component | Globus Medical, Inc. | LWJ | Class II | |
| K960765 | Mentor Advent A/b System | Mentor Ophthalmics, Inc. | IYO | Class II | |
| K960625 | Spreadable Sheath Introducer Set | Neostar Medical Technologies, Inc. | DYB | Class II | |
| K955916 | Townley Total Elbow System | Biologically Oriented Prostheses | JDC | Class II | |
| K955525 | Flower Infusion Catheter Model F-25/50, F-60/70 | Interventional Innovations Corp. | KRA | Class II | |
| K955270 | Tape & Bandage, Adhesive | Robert R. Stevens | DXC | Class II | |
| K954996 | Trend Amebiasis (E.histolytica) Serological Elisa Test System | Trend Scientific, Inc. | KHW | Class II | |
| K954987 | Altratouch 1000 Hemodialysis Delivery System | Althin Medical AB an Affiliate of Baxter Intl | KDI | Class II | |
| K954769 | Biegler Bw385l Blood & Infusion Warmer | Biegler Medical Products, Inc. | LGZ | Class II | |
| K954028 | Hp Sonos Ultrasound Imaging System | Hewlett-Packard Co. | IYN | Class II | |
| K962606 | Topographic Imaging Marker | Izi Medical Products LLC | JAA | Class II | |
| K962333 | V.r.s. Denture Resin Material | Vident | EBI | Class II | |
| K962086 | Cps, Cemented Cup System | Artos Medical Products GmbH | JDI | Class II | |
| K961918 | Multi-Test II | Lincoln Diagnostics, Inc. | SCL | Class II | |
| K961877 | Piston Syringe | Univec, Inc. | FMI | Class II | |
| K961858 | Cosgrove Depth Electrode Kit(cdek) | Radionics, Inc. | HAW | Class II | |
| K961472 | Dental Dam Silicone | Worldwide Dental, Inc. | EIE | Class I | |
| K961413 | Synthes Anatomical Locking Plate System | Synthes (USA) Products LLC | HWC | Class II | |
| K960976 | Kinematic II Replacement Tibial Inserts | Howmedica Corp. | JWH | Class II | |
| K960761 | Pathway Electromyograph Model Tr-10 & Tr-20 | The Prometheus Group | HCC | Class II | |
| K960544 | Cardio-Card Holter ECG Management System | Nasiff Assoc., Inc. | DRT | Class II | |
| K960422 | Pruitt Safety Occlusion Catheter | Ideas for Medicine, Inc. | MJN | Class II | |
| K955766 | Adult-Pediatric Transport System | International Biomedical, Ltd. | FPO | Class II | |
| K962743 | Pulpdent Sodium Hypochlorite Solution | Pulpdent Corporation | KJJ | Unclassified | |
| K962456 | Sr Antaris Anterior Teeth/sr Postaris Posterior Teeth | Ivoclar North America, Inc. | ELM | Class II | |
| K962071 | Spirit S1/s2 | KaVo Dental Technologies, LLC | EIA | Class I | |
| K961905 | Medicinelodge, Inc. Set Screw | Medicinelodge, Inc. | HWC | Class II | |
| K961901 | Bone & Marrow Collection System | Biomedical Ent., Inc. | GEY | Class I | |
| K961874 | Storz Dp5100 Anterior Collection Cassette Pack | Storz Instrument Co. | HQC | Class II | |
| K961831 | Storz Dp5200 Irrigation Addministration Set Pack | Storz Instrument Co. | HQC | Class II | |
| K961825 | Ultraset/3l Capd Disposable Disconnect Y-Set Models 5C4366 & 5C4493 | Baxter Healthcare Corporation | KDJ | Class II | |
| K961214 | Multi Leaf Collimator | Mitsubishi Intl. Corp. | IYE | Class II | |
| K960499 | Heartrak Xl | Universal Medical, Inc. | DXH | Class II |