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 |
|---|---|---|---|---|---|
| K243110 | eFOLDi Navigator Powerchair (STPC-A) | Suntech UK Limited | ITI | Class II | |
| K242670 | Lumify Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | JWH | Class II | |
| K233271 | OsseOne Dental Implant System | Synoross dba Osseone | DZE | Class II | |
| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | KTT | Class II | |
| K251111 | Cary | Excitus AS | JCX | Class II | |
| K250222 | SDF Pro | Belport Company, Inc., Gingi-Pak | PHR | Class II | |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific LLC | MOB | Class II | |
| K243684 | BrightHeart View Classifier | Brightheart | QIH | Class II | |
| K242975 | Mobility Scooter (Model X-01, X-02) | Wuyi Aichi Industry & Trade Co., Ltd. | INI | Class II | |
| K251094 | Alma Veil | WONTECH Co., Ltd. | GEX | Class II | |
| K250785 | Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | FGB | Class II | |
| K250253 | IPL Hair Removal Device (KCA511/KCA516/KCA522) | Dongguan Boyuan Intelligent Technology Co., Ltd | OHT | Class II | |
| K250160 | Ankyras | Mentice Spain S.L. | PZO | Class II | |
| K243017 | IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) | Foshan Newface Electronic Technology Co., Ltd. | OHT | Class II | |
| K241980 | !M1 | Solutions for Tomorrow AB | IZL | Class II | |
| K250728 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex GmbH | GCJ | Class II | |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | MYN | Class II | |
| K243603 | AeviceMD | Aevice Health Pte. Ltd. | DSH | Class II | |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | EBG | Class II | |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Boblingen GmbH | MHX | Class II | |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) | FYA | Class II | |
| K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | Zamar Medical d.o.o. | IRP | Class II | |
| K242386 | Bluemoon | GENOSS Co., Ltd. | EBZ | Class II | |
| K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | Thermasolutions LLC. | MLW | Class II | |
| K251071 | Fetal EchoScan (v1.1) | Brightheart | POK | Class II | |
| K251056 | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical Ltd. | QNM | Class II | |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | STERIS Corporation | JOJ | Class II | |
| K250629 | Sutil Rich Personal Lubricant | Hathor Professional Skincare Ltd. | NUC | Class II | |
| K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. | FOZ | Class II | |
| K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Medical | CHL | Class II | |
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | Karl Storz SE & Co. KG | FBO | Class II | |
| K243894 | F88 URE-SD/RD Flexible Ureteroscope | SG Endoscopy Pte Ltd | FGB | Class II | |
| K243828 | Cionic Neural Sleeve (Ns-200) | Cionic | GZI | Class II | |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | DQY | Class II | |
| K243457 | Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel | Seriously Clean Ltd | FRO | Unclassified | |
| K243114 | SQA-iOw Sperm Quality Analyzer | Medical Electronic Systems Ltd. | POV | Class II | |
| K243069 | Lumys (V1) | Intradys | LLZ | Class II | |
| K243043 | Origin™ Cemented Hip Stem | Signature Orthopaedics Pty Limited | LZO | Class II | |
| K242986 | SpO2 Extension Cable | Beijing Rongrui-Century Science & Technology Co., Ltd. | DSA | Class II | |
| K242763 | JetCan® Pro Safety Huber Needle | PFM Medical GmbH | FPA | Class II | |
| K242583 | AT-Patch (ATP-C130/ATP-C70) | ATsens Co., Ltd. | DSH | Class II | |
| K251014 | APRO 45 Catheter | Alembic LLC | DQY | Class II | |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | CIRCA Scientific, Inc. | DXF | Class II | |
| K250996 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | QOF | Class II | |
| K250995 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | QOF | Class II | |
| K250641 | APEX 3D Total Ankle Replacement System | Paragon 28 | HSN | Class II | |
| K250296 | Disposable Distal Attachment D-201 Series | Olympus Medical Systems Corp. | FDS | Class II | |
| K250087 | Vscan Air | GE Healthcare | IYN | Class II |