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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K190617 | Wrap accessory electrodes | Hi-Dow International Inc. | GXY | Class II | |
| K190351 | Site Seal SV | Ensite Vascular | DXC | Class II | |
| K183138 | Certain BellaTek Express and BellaTek Flex Abutments | ZimVie US Corp LLC | NHA | Class II | |
| K182876 | Uro-N Cystoscope | Uroviu Corporation | FAJ | Class II | |
| K190980 | Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter | Innovative Health, LLC. | DRF | Class II | |
| K190905 | BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) | Becton Dickinson & Co | LON | Class II | |
| K190550 | IKON 40 Manual Wheelchair | Broda Seating (Broda LP) | IOR | Class I | |
| K190524 | MRopen 0.5 T | ASG Superconductors S.p.A. | LNH | Class II | |
| K190166 | TriMed Nitinol Staple System | Trimed Inc | JDR | Class II | |
| K183173 | LIGHTMED Ultrasound System | Light-Med (USA), Inc. | IYO | Class II | |
| K183062 | ASAHI Silverway | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. | BWF | Class II | |
| K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures | Medos International SARL | MBI | Class II | |
| K191450 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | |
| K191223 | Navio | Blue Belt Technologies, Inc. | OLO | Class II | |
| K190696 | Stryker Surgeon iD Mandible Recon Plate | Stryker Corp. | JEY | Class II | |
| K190654 | Straumann CI RD Ceramic Healing Caps | Straumann USA, LLC | NHA | Class II | |
| K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) | ConMed Corporation | HTN | Class II | |
| K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | ConMed Corporation | HTN | Class II | |
| K190475 | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 | Centerpoint Systems LLC | DQY | Class II | |
| K190341 | iC-GN iC-Cassette for use on the iC-System | Icubate, Inc. | PEN | Class II | |
| K190251 | RecoveryRx | Bioelectronics Corporation | ILX | Class II | |
| K190101 | UltraFlex IAB | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | Class II | |
| K183389 | Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove | Hartalega NGC Sdn Bhd | KGO | Class I | |
| K183064 | TxTi IBF System | Innovasis, Inc | MAX | Class II | |
| K183021 | ClearEndoclip | Finemedix | PKL | Class II | |
| K181672 | SureTouch Mobile Pressure Mapping System | Sure, Inc. | NKA | Class II | |
| K191465 | Human IgM Kit for use on SPAPlus | The Binding Site Group Ltd. | CFN | Class II | |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | Erbe USA Inc | OCX | Class II | |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Acist Medical Systems, Inc. | OBJ | Class II | |
| K190782 | FlexGard Cut-Resistant Glove Liners | Ldi Corporation | KGO | Class I | |
| K190583 | DynaFlex | Dyna Flex | NXC | Class II | |
| K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K190080 | Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) | Comfort Rubber Gloves Industries Sdn Bhd | LZA | Class I | |
| K190017 | LiverMultiScan (LMSv3) | Perspectum Diagnostics, Ltd. | LNH | Class II | |
| K183602 | SwimCount Sperm Quality Test | Motilitycount ApS | POV | Class II | |
| K183183 | VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture | Ethicon, Inc | GAM | Class II | |
| K182733 | Rochal Bioshield Silicone Film | Rochal Industries, LLC | KMF | Class I | |
| K182683 | Z-Robot Patient Positioning System | Chinan Biomedical Technology, Inc. | JAI | Class II | |
| K191485 | Deflectable Brush Biopsy Set | Cook Incorporated | FDX | Class II | |
| K191166 | DigniCap Delta | Dignitana AB | PMC | Class II | |
| K191128 | Vantage Titan 3T, MRT-3010, V2.5 | Canon Medical Systems Corporation | LNH | Class II | |
| K190938 | Phototherapy System | Shanghai Apolo Medical Technology Co.,Ltd. | GEX | Class II | |
| K190299 | Elos Accurate® Customized Abutment | Elos MedTech Pinol a/S | NHA | Class II | |
| K190097 | Straumann CARES Screw-Retained Bridges and Bars | Straumann USA, LLC | NHA | Class II | |
| K190096 | R2gate | Megagen Implant Co., Ltd. | LLZ | Class II | |
| K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | O&M Halyard, Inc. | LZA | Class I | |
| K182832 | Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set | Cook Incorporated | KGC | Class II | |
| K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | DQA | Class II | |
| K191194 | Clarus | Carl Zeiss Meditec Inc | QER | Class II |