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 |
|---|---|---|---|---|---|
| K250373 | ProLift Expandable Spacer System | Life Spine | MAX | Class II | |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. | FTL | Class II | |
| K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. | BZQ | Class II | |
| K243819 | Luminopia | Luminopia Inc | QQU | Class II | |
| K243743 | autoSCORE (V 2.0.0) | Holberg EEG AS | OMB | Class II | |
| K243613 | Patch-TEA (Model TRI-21) | Transtimulation Research Inc | NUH | Class II | |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. | QBJ | Class II | |
| K242429 | CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System | Becton Dickinson Inc. (BD) | SEF | Class II | |
| K241589 | Ceribell Seizure Detection Software | Ceribell, Inc. | OMB | Class II | |
| DEN240021 | Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL)) | Active Protective Technologies, Inc. | SEC | Class II | |
| K250948 | TriMed Fusion Cup System | Trimed Inc | HRS | Class II | |
| K250708 | NPseal | Guard Medical, Inc. | OKO | Class II | |
| K250366 | Electric Wheelchair (LW01301A07) | Anhui Longway Medical Technology Co., Ltd | ITI | Class II | |
| K250343 | LuxCreo Clear Aligner System | Luxcreo Inc. | NXC | Class II | |
| K250136 | Globalcare Blood Pressure Monitor (GUS610) | Globalcare Medical Technology Co., Ltd | DXN | Class II | |
| K243967 | ONE Nitrile Condom | Global Protection Corp. | MOL | Class II | |
| K243749 | Jmoon Conductive Gel | Shenzhen Ulike Smart Electronics Co.,Ltd | GYB | Class II | |
| K243722 | Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) | Selio Medical Limited | OMT | Class II | |
| K243027 | Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) | Hangzhou Sightnovo Medical Technology Co., Ltd. | QLY | Class II | |
| K242552 | Horos Mobile | Icat Solutions Ltd | LLZ | Class II | |
| K242295 | BunkerHill BMD | Bunkerhill Health | KGI | Class II | |
| K242151 | Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) | Shenzhen Nuon Medical Equipment Co., Ltd. | OHS | Class II | |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. | MQV | Class II | |
| K250425 | Ultraviolet Phototherapy Device | Apk Technology Co., Ltd | FTC | Class II | |
| K250395 | BioBrace ® RC Delivery System | ConMed Corporation | ORQ | Class II | |
| K250033 | Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) | Guangzhou Pinzhi Medical Technology Co., Ltd | NUH | Class II | |
| K243567 | Tyto Insights for Rhonchi Detection | Tyto Care Inc. | PHZ | Class II | |
| K243143 | E-Pen (E-Pen) | Bomtech Electronics Co., Ltd. | QAI | Class II | |
| K242385 | LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co.,Ltd | OHS | Class II | |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co.,Ltd | NFT | Class II | |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | BIOTRONIK AG | LIT | Class II | |
| K250667 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | MAX | Class II | |
| K250656 | Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) | Wuhan Pioon Technology Co.,Ltd. | GEX | Class II | |
| K250332 | Virage® OCT Spinal Fixation System | Highridge Medical, LLC | NKG | Class II | |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) | TURBETT SURGICAL, Inc | FRG | Class II | |
| K243786 | Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K243769 | Qfr (3.0) | QFR Solutions BV | QHA | Class II | |
| K243691 | LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. | DQY | Class II | |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | FMI | Class II | |
| K243549 | JETi Hydrodynamic Thrombectomy System | Abbott Medical | QEZ | Class II | |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0) | Whoop, Inc. | QDA | Class II | |
| K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine Inc | MAX | Class II | |
| K242807 | HeartFocus (V.1.1.1) | Deski | QJU | Class II | |
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | Draegerwerk AG & Co. KGaA | BTL | Class II | |
| K242576 | AllTest Viral Transport Medium | Hangzhou AllTest Biotech Co.,Ltd | JSM | Class I | |
| K242209 | UASure II Blood Uric Acid Monitoring System | Apex Biotechnology Corp. | PTC | Class I | |
| K242116 | EyeBOX EBX-4.1 | Oculogica Inc. | QEA | Class II | |
| K242103 | TRIOS Ready Tip | 3SHAPE Trios a/S | NBL | Class II | |
| K242068 | LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co | OLP | Class II | |
| K242001 | Philips VSC-MEDlib | Philips Medical Systems Nederland B.V. | BZQ | Class II |