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 |
|---|---|---|---|---|---|
| K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) | Medtronic, Inc. | DQK | Class II | |
| K233899 | Knee+ | Pixee Medical | SBF | Class II | |
| K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | MEH | Class II | |
| K233705 | CellFX Percutaneous Electrode System (SYS3000) | Pulse Biosciences, Inc. | GEI | Class II | |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated | GWJ | Class II | |
| K233438 | SleepStageML | Beacon Biosignals, Inc. | OLZ | Class II | |
| K233421 | Rescan 700 | Carl Zeiss Meditec Inc | OBO | Class II | |
| K233359 | DOMINION Expandable Corpectomy System | Astura Medical | MQP | Class II | |
| K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | OSSIO, Ltd. | HWC | Class II | |
| K233177 | Nest VT Vitrification Device | Cook Incorporated | MQK | Class II | |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. | MWI | Class II | |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) | STERIS Corporation | FBK | Class II | |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co.,Ltd. | DJG | Class II | |
| K231813 | Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. | ODG | Class II | |
| K231760 | Hp-Oct (Hp-Oct) | Cylite Pty., Ltd. | HJO | Class II | |
| K231734 | STERiJECT Low Dead Space, STERiJECT The Invisible Needle | TSK Laboratory International Japan KK | QNS | Class II | |
| K231056 | Esperance Distal Access Catheter | Wallaby Medical | QJP | Class II | |
| K230195 | Neo ADVISE software | Comerge AG | OLO | Class II | |
| K240458 | Synthetic Bone Putty | Ventris Medical | MQV | Class II | |
| K240407 | ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor | Stryker Corp. | MBI | Class II | |
| K240371 | 0909Fcc, 0909Fcc-Hs | Rayence Co., Ltd. | MQB | Class II | |
| K233692 | Voluson Signature 20, Voluson Signature 18 | GE Healthcare | IYN | Class II | |
| K232781 | Safety Sliding Blood Collection Set | Jiangsu Caina Medical Co., Ltd | JKA | Class II | |
| K232207 | D·Kutting™ PTA Scoring Balloon Dilatation Catheter | DK Medical Technology Co., Ltd. | PNO | Class II | |
| K240619 | e-SDF | Kids-e-Dental LLP | PHR | Class II | |
| K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | STERIS Corporation | ODC | Class II | |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | Assure Tech LLC | NGL | Class II | |
| K240273 | Access Free T4 | Siemens Healthcare Diagnostics Inc. | CEC | Class II | |
| K233880 | Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) | Shenzhen Root Innovation Technology Co., Ltd. | HGX | Class II | |
| K233794 | Insulin Syringe | SPM Medicare Pvt, Ltd. | FMF | Class II | |
| K233572 | Autofuse | Pymedix | LLZ | Class II | |
| K233075 | “BioGend” Interbody Fusion System 001 Cage | BioGend Therapeutics Co., Ltd | MAX | Class II | |
| K233021 | BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device | Care Fusion | LHI | Class II | |
| K232703 | Disposable Bipolar Forceps | Jiangsu Hope Biomedical Science&Technology Co.,Ltd. | GEI | Class II | |
| K232424 | CurrentBody Skin RF | El Global Trade Ltd. | PAY | Class II | |
| K232270 | DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. | JOW | Class II | |
| K232004 | Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector | Medivators (A Subsidiary of Steris Corporation) | ODC | Class II | |
| K231786 | Gynethotics™ Pessary | Cosm Medical | HHW | Class II | |
| K231677 | EdgeFlow UH10 | Edgecare Inc. | IYO | Class II | |
| K231497 | Choledochoscope System | Shenzhen Hugemed Medical Technical Development Co., Ltd | FBN | Class II | |
| K231403 | evoDrill Cranial Perforator | Evonos GmbH & Co. KG | HBF | Class II | |
| K240597 | Tera Harz Clear | Graphy Inc. | NXC | Class II | |
| K240459 | Cerament Bone Void Filler | Bonesupport Inc | MQV | Class II | |
| K240404 | NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) | Novabone Products, LLC | MQV | Class II | |
| K240090 | Argo Knotless GENESYS Anchor | ConMed Corporation | MAI | Class II | |
| K234070 | Stelo Glucose Biosensor System | Dexcom, Inc. | SAF | Class II | |
| K233859 | Basis Flow II | Yamahachi Dental Mfg. Co. | EBI | Class II | |
| K233526 | Medline Open-back Level 3 Protective Gown | MEDLINE INDUSTRIES, LP - Northfield | QPC | Class II | |
| K231260 | HTx Disposable Hysteroscope System | Suzhou Acuvu Medical Technology Co., Ltd. | HIH | Class II | |
| K231210 | DGA Abutment | Modern Dental Laboratory (DG) Co., Ltd. | NHA | Class II |