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 |
|---|---|---|---|---|---|
| K242529 | Tigon Medical All-Suture Anchors (ASA) | Tigon Medical LLC | MBI | Class II | |
| K242362 | Lightning Viewer | Nexsys Electronics Inc. dba Medweb | LLZ | Class II | |
| K242281 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | FOZ | Class II | |
| K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Healthcare | IYN | Class II | |
| K241888 | Single-use Balloon Dilatation Catheter | Leo Medical Co., Ltd. | FGE | Class II | |
| K241680 | Momcozy Wearable Breast Pump (BP311) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) | Beijing Adss Development Co., Ltd. | GEX | Class II | |
| K241652 | DASH® SARS-CoV-2 & Flu A/B Test | Nuclein, LLC | QOF | Class II | |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn Inc | MWI | Class II | |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | Andon Health Co., Ltd | LCX | Class II | |
| K241167 | BioSphere Putty; BioSphere MIS Putty | Synergy Biomedical | MQV | Class II | |
| K240435 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | DZE | Class II | |
| K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical Inc | NEU | Class II | |
| K243725 | BD Vaginal Panel | Becton Dickinson & Co | PQA | Class II | |
| K243705 | Saige-Density (2.5.0) | Deephealth | QIH | Class II | |
| K243688 | Saige-Dx (3.1.0) | Deephealth | QDQ | Class II | |
| K243652 | Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) | Cardinalhealth | PNR | Class II | |
| K243595 | OviTex PRS (Long-Term Resorbable) | Tela Bio, Inc. | FTM | Class II | |
| K243440 | Electric Wheelchair (HC820N) | Yongkang Hengyi Vehicle Co.,Ltd | ITI | Class II | |
| K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | NFO | Class II | |
| K243361 | Nutrifit | Vygon U.S.A. | FPD | Class II | |
| K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | MQB | Class II | |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K243094 | Quickdent Dental Implant System | Quickdent Devices Private Limited | DZE | Class II | |
| K243071 | Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc | KGN | Unclassified | |
| K242954 | Integrity V500 (Integrity, Integrity with VEMP) | Vivosonic Inc. | GWJ | Class II | |
| K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | Shanghai Sigma High-Tech Co., Ltd. | FTC | Class II | |
| K242892 | Cristaline Aligners Z FLX | Cristaline Aligners GmbH | NXC | Class II | |
| K242819 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | NHA | Class II | |
| K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) | Shenzhen Nuon Medical Equipment Co., Ltd. | OHS | Class II | |
| K242467 | Iq-Uip | Imbio, Inc. | QWO | Class II | |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) | MEDLINE INDUSTRIES, LP - Northfield | GEI | Class II | |
| K242270 | OrthoNext Platform System | Orthofix SRL | QIH | Class II | |
| K242063 | LibAirty Airway Clearance System | Synchrony Medical Ltd | BYI | Class II | |
| K241778 | Hudson RCI Comfort Flo® CubCannula™ | MEDLINE INDUSTRIES, LP - Northfield | BTT | Class II | |
| K241768 | Broadway 8 Catheter | Stryker Corp. | QJP | Class II | |
| K241637 | Echo Intracranial Base Catheter | Stryker Corp. | QJP | Class II | |
| K241322 | Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) | Joytech Healthcare Co., Ltd. | HGX | Class II | |
| K241168 | System 83 Revolve Endoscope Washer/Disinfector | Wassenburg Medical B.V. | FEB | Class II | |
| K240885 | Shadow Catheter | Simpson Interventions, Inc. | DQY | Class II | |
| K240348 | Quantum Mitohormesis (QMT) (M2101) | Quantumtx Pte. Ltd. | IPF | Class II | |
| K232813 | Therapy EC, Therapy XT | DMC Importacao e Exportacao de Equipamentos Ltda | NHN | Class II | |
| DEN240014 | ARC-EX System | ONWARD Medical Inc. | SDO | Class II | |
| K243720 | 3Delta UNlimited | Deltamed GmbH | EBF | Class II | |
| K243625 | Xpert MRSA/SA SSTI | Cepheid | NQX | Class II | |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.p.A. | MBH | Class II | |
| K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) | ETEX Corporation | MQV | Class II | |
| K243128 | Klockner Kits | Soadco, S.L. | KCT | Class II | |
| K242787 | Tens & Ems Device (TU1080) | Changsha Anxiang Medical Technology Co., Ltd | NGX | Class II | |
| K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix Ltd. | JOP | Class II |