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 |
|---|---|---|---|---|---|
| K252425 | Silatrix Oral Gel | Sa3, LLC | OLR | Unclassified | |
| K252384 | DESS® Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K252345 | Picosecond Laser Device (PF131-BI) | Risu Medical Technology Co., Ltd. | GEX | Class II | |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | DYB | Class II | |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K250288 | TeraRecon Cardiovascular.Calcification.CT | Terarecon, Inc. | QIH | Class II | |
| K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | |
| K253145 | Pre-Sutured Tendon | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | GAT | Class II | |
| K253144 | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics Inc. | JWH | Class II | |
| K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | QJP | Class II | |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | Qiagen | PCH | Class II | |
| K252325 | Hair Growth Laser Cap | Cosmo Far East Technology Limited | OAP | Class II | |
| K252322 | SIros-X System | Genesys Spine | OUR | Class II | |
| K252298 | Andi 2.0 | Imeka Solutions Inc. | QIH | Class II | |
| K251977 | electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X) | Ningbo Youhe Electrical Appliance Technology Co., Ltd. | HGX | Class II | |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | Acon Laboratories, Inc. | SCA | Class II | |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | GE Healthcare | FMZ | Class II | |
| K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | LRK | Class II | |
| K251289 | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | QVF | Class II | |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) | Intervene Inc | QEW | Class II | |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical, Inc. | LLZ | Class II | |
| K250955 | XC11 ICE System, USA | Yorlabs, Inc. | OBJ | Class II | |
| K250666 | Alegria Flash CTD Screen | Zeus Scientific LLC | LLL | Class II | |
| K253249 | TriALTIS™ Spine System | Medos International SARL | NKB | Class II | |
| K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | MBI | Class II | |
| K253034 | HemoSphere Stream Module | Edwards Lifesciences LLC | DQK | Class II | |
| K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare Ltd. | ONB | Class II | |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | NKB | Class II | |
| K251838 | Introducer Sheath Set | Cardiocycle Medical(suzhou) Co.,Ltd. | DYB | Class II | |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut fur Physik und Medizin GmbH | KOI | Class II | |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corp. | FGE | Class II | |
| K250394 | Fine TTO™ | Bodycad Laboratories, Inc. | PBF | Class II | |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | LivsMed Inc. | GEI | Class II | |
| K231897 | NeuroAlign software | Medivis, Inc. | HAW | Class II | |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc | MOS | Class II | |
| K252665 | brAIn™ Shoulder Positioning | Avatar Medical | QIH | Class II | |
| K252640 | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | GCJ | Class II | |
| K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U) | Sanhe LEFIS Electronics Co.,Ltd | GEX | Class II | |
| K252277 | Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Ltd | DSY | Class II | |
| K252155 | AVAVA™ Skin Treatment System | Avava, Inc. | ONG | Class II | |
| K251414 | Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) | Feeltech Co.,Ltd. | NEW | Class II | |
| K242827 | A8 INTEGR8™ Porous Pedicle Screws | ALLUMIN8 Inc | NKB | Class II | |
| K252266 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | NHA | Class II | |
| K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) | Shenzhen Zhenxing Ruitong Technology Co., Ltd. | OHS | Class II | |
| K252254 | Osteotomy Wedge System | Sinaptic Surgical | PLF | Class II | |
| K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | LZA | Class I | |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | Stryker Corp. | HCG | Class II | |
| K251778 | Remi Custom Night Guard | Remi | OBR | Unclassified | |
| K251673 | X9 Ultrasound System | X9 Inc. | SGH | Class II | |
| K251355 | X1-Ffr | Spectrawave, Inc. | QHA | Class II |