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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K240639 | PINNACLETM Constrained Acetabular Liners | Depuy Ireland UC | KWZ | Class II | |
| K240361 | Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co.,Ltd | LZA | Class I | |
| K240172 | Preview Shoulder | Genesis Software Innovations | QIH | Class II | |
| K240071 | Peleton Universal Single Use Power System and Attachments | Peleton Surgical | SAM | Class I | |
| K240038 | Clear Moves Aligners | Space Maintainers Laboratories (Sml) | NXC | Class II | |
| K233910 | Vertex Hip Fracture Nailing System | Orthoxel Dac | HSB | Class II | |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | ESW | Class II | |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer | Midmark Corp | FLE | Class II | |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | MQP | Class II | |
| K232227 | Ablate-Iq | Neuwave Medical, Inc. | JAK | Class II | |
| K232114 | TRIBRID® Unicompartmental Knee System | Kyocera Medical Technologies, Inc. | HSX | Class II | |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | Innovative Health, LLC. | PNE | Class II | |
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia, Inc. | GKA | Class II | |
| K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | GWO | Class II | |
| K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers Inc. | HQD | Class II | |
| K240350 | AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. | NKB | Class II | |
| K240282 | IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) | Dongguan Boyuan Intelligent Technology Co., Ltd | OHT | Class II | |
| K240135 | Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | |
| K233618 | Oxevision Sleep Device | Oxehealth Ltd | LEL | Class II | |
| K233548 | Uresta® | Resilia Inc. | HHW | Class II | |
| K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutions USA, Inc. | QKB | Class II | |
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC | NXC | Class II | |
| K230889 | Digital Thermometer | Wenzhou Yosun Medical Technology Co., Ltd. | FLL | Class II | |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona Inc | EMA | Class II | |
| K240601 | SnapshotNIR model KD205 | Kent Imaging Inc | MUD | Class II | |
| K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Syntex Healthcare Products Co., Ltd. | LZA | Class I | |
| K233975 | Zoom 6F Insert Catheters | Imperative Care Inc. | DQO | Class II | |
| K233750 | ECG-less Cardiac | GE Healthcare | JAK | Class II | |
| K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | JAK | Class II | |
| K232112 | R&G Surgical Mask | R & G Seguridad e Higiene Industrial S.A.C. | FXX | Class II | |
| K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System | Affinity Biosensors | SAN | Class II | |
| DEN230036 | Sepsis ImmunoScore | Prenosis, Inc. | SAK | Class II | |
| K240635 | ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm | Ximedica | GCJ | Class II | |
| K240442 | MagnetOs Putty | Kuros Biosciences BV | MQV | Class II | |
| K240397 | AlphaVac MMA F1885 System (H787253020) | Boston Scientific Corporation | QEZ | Class II | |
| K240288 | SF Push- in Anchor | SURGICAL FUSION TECHNOLOGIES GmbH | MAI | Class II | |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse | Microport Orthopedics Inc. | KRO | Class II | |
| K233990 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | Shandong Xingyu Gloves Co., Ltd | LZA | Class I | |
| K233676 | Us2.v2 | Eko.Ai Pte Ltd. D/B/A Us2.Ai | QIH | Class II | |
| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical LLC | MWI | Class II | |
| K232726 | External Hex Implant System | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Cefla S.C. | EBW | Class I | |
| K231209 | Rejoyn | Otsuka America Pharmaceutical, Inc | SAP | Class II | |
| K240608 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K240587 | SmoothSkin Pure Unplugged (SSB3) | Cyden Limited | OHT | Class II | |
| K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | |
| K233622 | AlignRT Plus | Vision Rt Inc | IYE | Class II | |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | Genesys Spine | OLO | Class II | |
| K233211 | Aview Cac | Coreline Soft Co., Ltd. | QIH | Class II |