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 |
|---|---|---|---|---|---|
| K071574 | Stiffer Coaxial Micro-Introducer Kit | Greatbatch Medical | DYB | Class II | |
| K071542 | Digital Stereoloc II | Hologic, Inc. | IZH | Class II | |
| K071113 | Rt300-S, Model Fa100052, Rt300-Sp (Pediatric Version), Model Fa100053 | Restorative Therapies Inc. | GZI | Class II | |
| K071088 | Life Latch Sharps & Biohazard Container | M&M Industries, Inc. | FMI | Class II | |
| K071022 | Powder-Free Vinyl Examination Gloves | Glormed Colombia S.A. | LYZ | Class I | |
| K070983 | Olympus Xbf-Uc180f-Dt8 Ultrasonic Bronchofibervideoscope Used with Aloka Ssd-Alpha 5/10 Ultrasound System | Olympus Medical Systems Corp. | PSV | Class II | |
| K070811 | Cordless Portable Dental X-Ray System, Model Adx4000 | Dexco | MUH | Class II | |
| K070663 | A-Dec/w&h Synea Air-Driven Highspeed Handpiece, Model Ta-98, Ta-97, a-Dec/w&h Synea Handpiece Attachment | A-dec, Inc. | EFB | Class I | |
| K070317 | Zeus Scientific, Inc Vzv Igm Elisa Test System | Zeus Scientific LLC | LFY | Class II | |
| K062584 | Pressio Icp Monitoring System | Sophysa | GWM | Class II | |
| K043579 | Atricure Bipolar System | AtriCure, Inc. | OCL | Class II | |
| K071675 | Liquichek Tumor Marker Control | Bio-Rad Laboratories Inc. | JJY | Class I | |
| K071622 | Arthrex Fiberwire | Arthrex GmbH | GAT | Class II | |
| K071253 | Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface, Model Cb4014 | Medtronic, Inc. | DTM | Class II | |
| K071156 | Sounmed Sd-2000 Plus Portable Ultrasound Scanner | Sounmed, Inc. | IYO | Class II | |
| K071155 | Modification to: Biosorb Resorbable Void Filler | Science for Biomaterials | MQV | Class II | |
| K070978 | Zimmer Segmental System | Zimmer GmbH | KRO | Class II | |
| K070973 | Quantum Spinal System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NKB | Class II | |
| K070730 | Flex-Neck Arc Catheter | Medigroup | FJS | Class II | |
| K070689 | Lg Sperm Freezing | <Genx> Intl., Inc. | MQL | Class II | |
| K070298 | Modification to Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | GEX | Class II | |
| K063063 | Silvacide Skin & Wound Moisturizing Solution | Medical Molecular Therapuetics, LLC | FRO | Unclassified | |
| K062824 | Aos Universal Conecting Guide Tube | Alpha Omega Services Inc | JAQ | Class II | |
| K062377 | Medapps Remote Patient Monitoring, Model Ma 100 | Medapps, Inc. | NBW | Class II | |
| K071645 | Model Hbp T-105 Series, Model T-105 and T-105S | Omron Healthcare Co., Ltd. | MWI | Class II | |
| K071569 | Allthread Peek Anchor with Tantalum Marker | Zimmer GmbH | MBI | Class II | |
| K071334 | Depuy Cas Hemi Asr Hip Instruments | Depuy Orthopaedics Inc. | HAW | Class II | |
| K070903 | Mylab40 | Esaote Europe B.V. | ITX | Class II | |
| K070846 | Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System | Prosurg, Inc | FTL | Class II | |
| K070743 | Z6 Stimulator | St Cardio Technologies, LLC | JOQ | Class II | |
| K070516 | Powerlaser | Powermedic ApS | ILY | Class II | |
| K063837 | Sigma M | Palodex Group Oy | MUH | Class II | |
| K063133 | Cranial Solution Orthosis | Cranial Solutions | MVA | Class II | |
| K071543 | Halo360' Coagulation Catheter | Barrx Medical, Incorporated | GEI | Class II | |
| K071497 | Atlas Spine Vertebral Body Replacement | Atlas Spine, Inc. | MQP | Class II | |
| K071495 | Expedium 4.5Mm Spine System | Depuy Spine, A Johnson & Johnson Company | NKB | Class II | |
| K071488 | Realhand High Dexterity (Hd) Instruments | Novare Surgical Systems, Inc. | GCJ | Class II | |
| K071394 | Modification To:sbi Ringfix | Small Bone Innovations, Inc. | KTT | Class II | |
| K071352 | Ceradrill | Gebr. Brasseler GmbH & Co. KG | EJL | Class I | |
| K071278 | Embrace Dual Cure Composite Materials | Pulpdent Corporation | EBF | Class II | |
| K071257 | Mini Quickanchor and Quickanchor Plus with Orthocord | DePuy Mitek, Inc. | JDR | Class II | |
| K071234 | Acunav Diagnostic Ultrasound Catheter 8F and 10F | Siemens Medical Solutions USA, Inc. | OBJ | Class II | |
| K071226 | 8Fr Turbo Booster, Guide Catheter, 7Fr Turbo Booster, Model 518-063, 518-043 | Spectranetics Corp. | PDU | Class II | |
| K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew | Arthrex GmbH | HWC | Class II | |
| K071090 | Trabecular Metal Glenoid- B/f Complete Shoulder Solution | Zimmer Trabecular Metal Technology, Inc. | KWS | Class II | |
| K071066 | Spycatch Stone Retrieval Basket | Boston Scientific Corporation | LQR | Class II | |
| K071058 | Multiple Patient Receiver, Model Org-9700A | Nihon Kohden America Inc | DRG | Class II | |
| K071053 | Recap Ha Press-Fit Femoral Resurfacing Head | Zimmer GmbH | KXA | Class II | |
| K071050 | Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy System | Coolsystems, Inc. | IRP | Class II | |
| K071030 | Bionexia Hcg Pregnancy Serum/urine Cassette and Dipstick Tests, Models 08-Hcgc and 02-Hcgc | Applied Dna Technologies, Inc. | JHI | Class II |