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 |
|---|---|---|---|---|---|
| K072551 | Ld-I 75 and Ld-I 200 | Meditech International Inc | NHN | Class II | |
| K071517 | Ap Medical Sharps Containers 0,6-12 Lt. | A.B.M. Italia S.P.A | MMK | Class II | |
| K070584 | Smart-Rod | Duoject Medical Systems, Inc. | LHI | Class II | |
| K080131 | Vpap St | ResMed Corp | BZD | Class II | |
| K073434 | Bipore Accuflex Percutaneous Sheath Introducer | Bipore, Inc. | DYB | Class II | |
| K073137 | Glucosure Voice Blood Glucose Monitoring System, Model As90011e1 | Apex Biotechnology Corp. | NBW | Class II | |
| K072658 | Advia Chemistry C-Reactive Protein_2, (Crp_2) and Calibrators | Siemens Healthcare Diagnostics Inc. | DCN | Class II | |
| K071626 | Durex Play Soft & Sensual Lubricant | Ssl Americas, Inc. | NUC | Class II | |
| K080698 | Gel Mark Ultracor Biopsy Site Marker, Model: Gmuc-17Ggp | Senorx, Inc. | NEU | Class II | |
| K080610 | Arthrocare Orthowand Surgical Device | ArthroCare Corporation | GEI | Class II | |
| K080271 | Inreach System | Medtronic, Inc. | JAK | Class II | |
| K073706 | Respiratory Humidifier, Model Mr850 | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K073075 | Frialit Plus, Xive S Plus, Xive Tg Plus, Ankylos Plus, Dental Implant Systems | Dentsply International, Inc. | DZE | Class II | |
| K070310 | B R a H M S Pct Sensitive Kryptor Test System | Brahms Aktiengesellschaft | NTM | Class II | |
| K080402 | Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38 | Encore Medical, LP | KWS | Class II | |
| K073713 | Blue Sky Bio Dental Implant System | Blue Sky Bio, LLC | DZE | Class II | |
| K073673 | Soyala Full Face Mask Gel Vented | Weinmann Gerate Fur Medizin GmbH + Co. KG | BZD | Class II | |
| K073550 | Prefense Edns-9000 Series Nurse Central Station | Nihon Kohden America Inc | MHX | Class II | |
| K073519 | Quickcat Extraction Catheter, Model 60090-01 | DSM Biomedical, Inc. | QEZ | Class II | |
| K073278 | Spinous Process Plate System | NuVasive Inc | KWP | Class II | |
| K072847 | Apex 2.0 Software for Qdr X-Ray Bone Densitometers | Hologic, Inc. | KGI | Class II | |
| K071489 | Homecheck Multiple Drug Cup Test | Tianjin New Bay Bioresearch Co., Ltd. | DKZ | Class II | |
| K080758 | Avs Pl Peek Spacers, Models 48351 and 48353 | Stryker Corp. | MAX | Class II | |
| K080717 | Habib Hexablate 10 | Emcision, Ltd. | GEI | Class II | |
| K080548 | Hd7 Diagnostic Ultrasound System | Phillips Medical Systems | IYN | Class II | |
| K080228 | Oralief OTC Toothpaste for Sensitive Teeth | Novamin Technology, Inc. | LBH | Class II | |
| K073111 | Portrait Psr, Model 745915 | Rhytec Incorporated | GEI | Class II | |
| K072730 | Friadent Cercon and Ankylos Cercon Balance Abutments | Dentsply Intl. | NHA | Class II | |
| K072403 | Non-Sterile, Powdered, Pink Latex Examination Gloves with Cherry Flavour and Protein Labeling Claims (200 Ug or Less) | Sgmp Co., Ltd. | LYY | Class I | |
| K072400 | Non-Sterile, Powder-Free, Black Nitrile Examination Gloves | Sgmp Co., Ltd. | LZA | Class I | |
| K072185 | Airistar Air Purification System, Model 500 & 1000 | Airistar Technologies, LLC | FRF | Class II | |
| K061907 | Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and Accessories | GE Healthcare | OLW | Class II | |
| K080514 | Pecd-01 and Pecd Quick-01 | 3M Espe AG Dental Products | ELW | Class II | |
| K080264 | Modification to: Fox Plus Pta Catheter | Abbott Vascular-Vascular Solutions | LIT | Class II | |
| K080203 | Mta Root Canal Sealer | Dentsply Interntional | KIF | Class II | |
| K080184 | Distal Humeral Plates with Angular Stability | I.T.S. Implantat-Technologie-Systeme GmbH | HRS | Class II | |
| K080104 | Vari-Lase Endovenous Laser Console, Model 7542 | Vascular Solutions LLC | GEX | Class II | |
| K073699 | Mct-Diabetes | Mycare Team, Inc. | NBW | Class II | |
| K073671 | Plicator Gsx Suturing System, Plicator Gsx, Plicator Instrument, Plicator Gsx Suture Cartridge | Ndo Surgical, Inc. | OCW | Class II | |
| K073583 | Modification to Palomar Lux1540 Handpiece | Palomar Medical Products, Inc. | GEX | Class II | |
| K073342 | Salvin Dental Specialties, Inc., Fixation Screw | Salvin Dental Specialties, LLC | DZL | Class II | |
| K073262 | Bella | Beekley Corporation | IZH | Class II | |
| K063813 | Ventlab Nasal CO2 Sampling/o2 Delivery Cannula | Salter Labs | CCK | Class II | |
| K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000 and Control Set Amphetamine 500 | Roche Diagnostics GmbH | DIF | Class I | |
| K080170 | Agento I.c. Silver-Coated Endotracheal Tube (Ihvlp) | C.R. Bard Inc | BTR | Class II | |
| K080101 | Aap Cannulated Screw and Darco Headed Screw | AAP Implantate AG | HWC | Class II | |
| K073455 | E-Vac | New Leaf Medical, Inc. | GEI | Class II | |
| K072441 | Ez Scan Plus Blood Glucose Monitoring System | Tyson Bioresearch, Inc. | NBW | Class II | |
| K072329 | Scoutpro 8F, 7F and Slitter Tool Advanced | BIOTRONIK AG | DQY | Class II | |
| K072321 | Bioflex | Biospine Co., Ltd. | NQP | Class II |