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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K143616 | AccuLIF TL and PL Cage | Stryker Corp. | MAX | Class II | |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | Galil Medical Ltd. | GEH | Class II | |
| K143526 | The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) | Thermo Fisher Scientific Oy | JWY | Class II | |
| K143388 | Affix IIS Spinous Process Plate System | Nu Vasive, Incorporated | PEK | Class II | |
| K143160 | FOXTROT NC PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd | LOX | Class II | |
| K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | Cossington, Ltd. | LOD | Class II | |
| K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta | Cossington, Ltd. | LOD | Class II | |
| K143094 | QuantaFlo | Semler Scientific, Inc. | JOM | Class II | |
| K142960 | Propeller System 2014-R | Reciprocal Labs Corporation | CAF | Class II | |
| K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | LLZ | Class II | |
| K142464 | Entriport | ConMed Corporation | GCJ | Class II | |
| K142438 | Nerve Monitoring Cable System | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | PDQ | Class II | |
| K141975 | Waterlase Iplus S | Biolase, Inc. | GEX | Class II | |
| K141740 | Infinity (Tm) Total Ankle System; Inbone Total Ankle System | Wrightmedicaltechnologyinc | HSN | Class II | |
| K141655 | Quanta Flash Ro52, Quanta Flash Ro52 Calibrators, and Quanta Flash Ro52 Controls | Inova Diagnostics, Inc. | OBE | Class II | |
| K141518 | Nellcor Bedside Respiratory Patient Monitoring System | Medtronic, Inc. | DQA | Class II | |
| K141467 | Surgical Gown | Xuchang Zhengde Environstar Medical Products Co.,L | FYA | Class II | |
| K140943 | Mastro Plus Balloon in-Deflation Device | Beijing Demax Medical Technology Co., Ltd. | MAV | Class II | |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | Spectranetics Corp. | DRE | Class II | |
| K150309 | Extremity Medical Calcaneal Osteotomy Device | Extremity Medical, LLC | HWC | Class II | |
| K150249 | ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System | Zonare Medical Systems, Inc. | IYN | Class II | |
| K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific LLC | LAF | Class II | |
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System | GE Vingmed Ultrasound AS | IYN | Class II | |
| K150004 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | KTT | Class II | |
| K143725 | Consensus Knee System Modular Tibial Baseplate | Consensus Orthopedics, Inc. | JWH | Class II | |
| K143673 | CMOS Video Nasopharyngoscope System | Schoelly Fiberoptic, GmbH | EOB | Class II | |
| K143645 | EsophyX® Z Fastener Delivery Device | Endogastric Solutions, Inc. | ODE | Class II | |
| K143552 | Simpliciti Shoulder System | TORNIER Inc. | PKC | Class II | |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece | Bien-Air Surgery SA | ERL | Class II | |
| K143485 | iGuide 2.1 | 3C-Medical Intelligence GmbH | IYE | Class II | |
| K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS | Zimmer GmbH | HRS | Class II | |
| K143087 | Hospira Blood Set | Abbott Medical | FPA | Class II | |
| K142990 | Insta-Gard Surgical and Procedure Face Mask | Cardinal Health200, LLC | FXX | Class II | |
| K142983 | AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating | Spectranetics Corp. | PNO | Class II | |
| K142953 | OCT-Camera | Optomedical Technologies GmbH | HLI | Class II | |
| K142916 | SVED Wound Treatment System | Cardinalhealth | OMP | Class II | |
| K142732 | T3 Software | Etiometry Inc. | MWI | Class II | |
| K133789 | Dolphin Neurostim OTC | Acumed Medical Ltd. | NUH | Class II | |
| K130238 | Nihon Kohden Ae-918P Neuro Unit | Nihon Kohden Corp. | OMA | Class II | |
| K143301 | NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit | Integrated Healing Technologies | OMP | Class II | |
| K141867 | Accu-Chek Aviva Connect Blood Glucose Monitoring System | Roche Diagnostics GmbH | NBW | Class II | |
| K141825 | IDEAL Locking Plate System | Jiangsu Ideal Medical Science & Technology Co., LT | HRS | Class II | |
| K150085 | GE EchoPAC | GE Vingmed Ultrasound AS | LLZ | Class II | |
| K143453 | Mpact Double Mobility System | Medacta International SA | LPH | Class II | |
| K142734 | TRILLIUM Oval MR System | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K142338 | Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) | Thermo Fisher Scientific Oy | JWY | Class II | |
| K150201 | Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter | Spectranetics Corp. | DQY | Class II | |
| K143576 | Exactech Ambassador | Exactech, Inc. | KWQ | Class II | |
| K143439 | KATANA Zirconia | Kuraray Noritake Dental, Inc. | EIH | Class II |