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 |
|---|---|---|---|---|---|
| K231053 | Unicare (K-UNICARE-USA) | Tenscare Ltd. | NUH | Class II | |
| K231026 | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | |
| K230579 | Smart Wedge algorithm | Edwards Lifesciences LLC | DQK | Class II | |
| K223883 | Daye Tampon | Annes Daye, Ltd. | HEB | Class II | |
| K223867 | Ids Acth II | Immunodiagnostic Systems Ltd. | CKG | Class II | |
| K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | MNR | Class II | |
| K223539 | Dreem 3S | Beacon Biosignals, Inc. | OLZ | Class II | |
| K223526 | ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing | Smith & Nephew Medical Ltd | FRO | Unclassified | |
| K223163 | Sleepiz One+ | Sleepiz AG | DRT | Class II | |
| K222993 | Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs | Sentienx Sdn Bhd | KGO | Class I | |
| K220253 | Eco Abutment, Multiunit Abutment | Dio Corporation | NHA | Class II | |
| DEN230019 | AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) | Boston Scientific Corporation | QXH | Class II | |
| K231481 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | QOF | Class II | |
| K230871 | Extron 5; Extron 7 | DRTECH Corporation | OWB | Class II | |
| K230690 | Tandry Locking Plate System | Microware Precision Co., Ltd. | HRS | Class II | |
| K230588 | Aer-O-Scope Colonoscope System | GI View Inc. | FDF | Class II | |
| K230415 | Cadwell Guardian | Cadwell Industries Inc | GWF | Class II | |
| K223912 | InterCollagen® Guide | Sigmagraft, Inc. | NPL | Class II | |
| K223538 | Integrity Implant | Anika Therapeutics, Inc. | OWX | Class II | |
| K223167 | Spirair Nasal Septal Strap | Spirair, Inc | NHB | Class II | |
| K222773 | Feeding Tube | Anhui Tiankang Medical Technology Co., Ltd. | PIF | Class II | |
| K222772 | Oral/Enteral Syringe with ENFit connector | Anhui Tiankang Medical Technology Co., Ltd. | PNR | Class II | |
| K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K232126 | EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil | Medtronic, Inc. | GAG | Class II | |
| K232116 | CoreLink Navigation Instruments | Corelink, LLC | OLO | Class II | |
| K231491 | TA™ Stapler and Loading Unit with DST Series™ Technology | Medtronic, Inc. | GAG | Class II | |
| K231389 | Harvest Dental HD Gum Strip | Harvest Dental Products LLC | EBI | Class II | |
| K231087 | Guided Surgery Kit | Implant Direct Sybron Manufacturing LLC | DZI | Class II | |
| K230832 | Powdered Free Sterile Natural Rubber Latex Surgical Gloves | The Egyptian Company for Medical & Electronic Industries | KGO | Class I | |
| K230581 | TOPA12 Portable X-ray Unit | Neuf, Inc. | IZL | Class II | |
| K230577 | Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) | Medcare Saglik Urunleri Sanayi ve Ticaret Anonim Sirketi | FYA | Class II | |
| K230342 | Phototherapy System (OL-PDT950) | Shanghai Omni Laser Skinology Co., Ltd. | GEX | Class II | |
| K230314 | Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) | New Era Medicare Sdn Bhd | LZA | Class I | |
| K230298 | Celsi Monitor | Hadleigh Health Technologies | FLL | Class II | |
| K223922 | Somnum (V.1.1.2.) | Honeynaps Co., Ltd. | OLZ | Class II | |
| K223709 | Kyphoplasty Balloon Catheter | Jiangsu Changmei MedTech Co.,Ltd | HRX | Class II | |
| K223479 | AQUAbase nX | B.Braun Medical, Inc. | FIP | Class II | |
| K222148 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | GKZ | Class II | |
| DEN220073 | Revi System | Bluewind Medical Ltd. | QXM | Class II | |
| K232127 | 21Hq513d, 32Hl512d, 31Hn713d, 32Hq713d | LG Electronics.Inc | PGY | Class II | |
| K231838 | RxSight® Insertion Device (63002) | RxSight Inc. | MSS | Class I | |
| K231829 | Xenix Medical Sacroiliac Fixation System | Ht Medical D.B.A. Xenix Medical | OUR | Class II | |
| K231807 | primaLOK™ SP Interspinous Fusion System | Wenzel Spine | PEK | Class II | |
| K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchair | Sichuan AST Medical Equipment Co., Ltd | IOR | Class I | |
| K231583 | Route 92 Medical Full Length 054 Access System | Route 92 Medical, Head Quarters | QJP | Class II | |
| K231455 | Implant-One System | Implant Logistics, Inc. | NHA | Class II | |
| K231301 | Vscan Air | GE Healthcare | IYN | Class II | |
| K231094 | Annalise Enterprise CTB Triage-OH | Annalise-Ai Pty, Ltd. | QAS | Class II | |
| K223874 | BAROguard | Paragonix Technologies Inc. | KDN | Class II | |
| K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System | L&K Biomed Co.,Ltd. | NKB | Class II |