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 |
|---|---|---|---|---|---|
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line | MEDLINE INDUSTRIES, LP - Northfield | BZE | Class II | |
| K233971 | Arthrex AlloSync PushLock Suture Anchor | Arthrex GmbH | MAI | Class II | |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | |
| K232773 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K241259 | Amplatz Goose Neck Snare Kit | Medtronic, Inc. | MMX | Class II | |
| K240947 | TENSOR® Suture Button System | Globus Medical, Inc. | HTN | Class II | |
| K240834 | EcoFit® short stem cementless cpTi | implantcast GmbH | LZO | Class II | |
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | PKL | Class II | |
| K240598 | Maestro System (REF100) | Moon Surgical, Inc. | FQO | Class I | |
| K240251 | ANNE Chest | Sibel Health Inc. | DRG | Class II | |
| K233751 | Milieve (YPS-301BD) | Soterix Medical,Inc. | PCC | Class II | |
| K233587 | LOCATOR Angled Abutment (Various) | Zest Anchors LLC | NHA | Class II | |
| K231291 | Perforated Baskets | Richard Wolf Medical Instruments Corp. | KCT | Class II | |
| K241248 | Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) | Spectrum Medical Inc | DWF | Class II | |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | EBG | Class II | |
| K241218 | Tyber Medical Anatomical Plating System | Tyber Medical | HRS | Class II | |
| K241055 | Electro Lube NXT | STERIS Corporation | GEI | Class II | |
| K240969 | IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) | Shenzhen Semlamp Intelligent Technology Co., Ltd | OHT | Class II | |
| K240913 | Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E) | Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd | ITI | Class II | |
| K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | Anhui Miisen Intelligence Technology Co., Ltd. | EIH | Class II | |
| K240612 | Cina-Vcf | Avicenna.ai | QFM | Class II | |
| K240394 | multiFlux 1000 (F00012408) | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K240281 | Bone Suppression Software | Konica Minolta, Inc. | LLZ | Class II | |
| K240254 | Blood Pressure Monitor (TMB-2296-BT) | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K233842 | iHealth COVID-19 Antigen Rapid Test | iHealth Labs, Inc. | QYT | Class II | |
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | Vascular Solutions LLC | LOX | Class II | |
| K233591 | Stylus | Degania Silicone, Inc. | KNT | Class II | |
| K233295 | Lfr-260 | Evolution Optiks Limited | SBI | Class I | |
| K232943 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe | Abbott Medical | QNQ | Class II | |
| K232821 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | |
| K232738 | BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | IYE | Class II | |
| K232715 | Distinct® Digital Pregnancy Test | Acon Laboratories, Inc. | LCX | Class II | |
| K232601 | BroncTru™ Transbronchial Access Tool | Broncus Medical Inc | EOQ | Class II | |
| K232333 | Anti-bacterial bandage | Jinhua Jingdi Medical Supplies Co.,Ltd | FRO | Unclassified | |
| K232107 | °M Warmer System | Mequ A/S | LGZ | Class II | |
| K232080 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | FRO | Unclassified | |
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | DGC | Class II | |
| K223427 | Mimics Enlight CMF | Materialise N.V. | LLZ | Class II | |
| K222196 | Deep TMS System | Brainsway Ltd. | OBP | Class II | |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | Qiagen | PCH | Class II | |
| K241289 | SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | BioFire Diagnostics, LLC | QOF | Class II | |
| K240838 | Spectrum Spine Cervical Cage System | Spectrum Spine Inc | ODP | Class II | |
| K240687 | SofWave System | Sofwave Medical Ltd. | OHV | Class II | |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | DRT | Class II | |
| K233674 | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | JWJ | Class II | |
| K233126 | aetherSlide | Aetherai Co., Ltd. | QKQ | Class II | |
| K233025 | Revolution External Plating System | New Standard Device dba Metalogix | KTT | Class II | |
| K232934 | Sunsphere | Hangzhou Yangshun Medical Technology Co.,Ltd | KRD | Class II | |
| K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter | Zhejiang Curaway Medical Technology Co., Ltd | GEI | Class II |