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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K231274 | Natural Cycles | Natural Cycles Nordic AB | PYT | Class II | |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex GmbH | JDQ | Class II | |
| K223607 | Plum Duo™ Infusion System | Abbott Medical | FRN | Class II | |
| K223606 | LifeShield™ Infusion Safety Software Suite | Abbott Medical | PHC | Class II | |
| K223150 | APS Metal Plate & Screw System | A Plus Biotechnology Co., Ltd. | HRS | Class II | |
| K222103 | Nitrile Patient Examination Gloves, Powder Free, Pink Color | Shandong Yinghng Medical Products Co., Ltd. | LZA | Class I | |
| K220145 | Monaghan medical filtered mouthpiece kit | Monaghan Medical Corp. | CAF | Class II | |
| K220085 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | Kronus, Inc. | OIF | Class II | |
| K212766 | Maxiocel Chitosan Wound Dressing | Advamedica Inc. | KGN | Unclassified | |
| K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | EFB | Class I | |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | Ortho-Clinical Diagnostics, Inc. | DHX | Class II | |
| K230812 | Withings Scan Monitor 2.0 | Withings | DPS | Class II | |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) | Dongguan Shin YI Healthcare Products Factory | FYA | Class II | |
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Ansell Healthcare Products LLC | KGO | Class I | |
| K223590 | Access Folate Assay | Siemens Healthcare Diagnostics Inc. | CGN | Class II | |
| K222946 | Oneday Mini Implant System | Oneday Biotech | DZE | Class II | |
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter | Medtronic, Inc. | DQY | Class II | |
| K231811 | Zavation Connector System | Zavation Medical Products, LLC | NKB | Class II | |
| K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | Xiantao Zhibo Non-Woven Products Co., Ltd. | FYA | Class II | |
| K231503 | CUPTIMIZE™ Advanced | Depuy Orthopaedics Inc. | LLZ | Class II | |
| K231496 | TITAN 3-D Wedge System | Paragon 28 | PLF | Class II | |
| K231205 | GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray | Gurunanda LLC | LFD | Unclassified | |
| K230899 | qXR-PTX-PE | Qure.ai Technologies Inc | QFM | Class II | |
| K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K220938 | Nova HD+ | Aura Wellness, LLC | NGX | Class II | |
| DEN220052 | BrachyGel Vaginal Hydrogel Packing System | Brachyfoam, Inc. D/B/A Advaray | QXR | Class II | |
| K232185 | Sm-IV | Sedecal S.A. | IZL | Class II | |
| K231867 | Grappler Suture Anchor System | Paragon 28 | MBI | Class II | |
| K231763 | Stable-C Interbody System | Nexus Spine, L.L.C. | OVE | Class II | |
| K231731 | Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 | Mcgovern Medical School | KPS | Class II | |
| K231266 | Pediatric Nailing Platform Tibia | Orthopediatrics Corp | HSB | Class II | |
| K230486 | Cove Strip | SeaSpine Orthopedics Corporation | MQV | Class II | |
| K223813 | Aveta System 2.0 | Meditrina, Inc. | HIH | Class II | |
| K223560 | Plato 17 Microcatheter | Scientia Vascular | QJP | Class II | |
| K222245 | ACR Screw System | Biomaterials Korea Inc. | OAT | Class II | |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | Boston Scientific Corporation | MXD | Class II | |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | Ultradent Product, Inc. | EBC | Class II | |
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Stryker Corp. | GCJ | Class II | |
| K232153 | Avéli | Revelle Aesthetics, Inc. | OUP | Class II | |
| K232150 | ZSFab Cervical Interbody System | Zsfab Inc | ODP | Class II | |
| K232144 | Sterile Products of the APTUS System | Medartis AG | HRS | Class II | |
| K231777 | Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) | Olympus Winter & Ibe GmbH | GEI | Class II | |
| K231718 | Holmium Medical Laser | Allengers Global Healthcare Private Limited | GEX | Class II | |
| K231673 | P200te (A10700) | Optos PLC. | OBO | Class II | |
| K231457 | SPARK Scan | Spark Neuro, Inc. | GWQ | Class II | |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | Stryker Corp. | HRS | Class II | |
| K231257 | Pangea Utility Plating System, Pangea Platform | Stryker Corp. | HRS | Class II | |
| K231204 | Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App | Cochlear Ltd | PFO | Class II | |
| K231096 | Automatic Continuous Effusion Shunt (ACES) System ACES System | Pleural Dynamics, Inc. | KPM | Class II | |
| K231085 | 1.5T HD T/R Knee Array (10-F34127) | Shenzhen RF Tech Co., Ltd. | MOS | Class II |