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 |
|---|---|---|---|---|---|
| K252781 | Msfx Mikron Peek Cages | Mikron Makina Sanayi ve Tic. Ltd. Sti. | ODP | Class II | |
| K252780 | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | |
| K252754 | Wearable Electric Breast Pump (YM-8803) | Guangdong Youmeng Electrical Technology Co., Ltd. | HGX | Class II | |
| K252670 | Alzevita | Topia MedTech Limited | QIH | Class II | |
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | NEZ | Class II | |
| K252342 | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) | Guangdong Youmeng Electrical Technology Co., Ltd. | HGX | Class II | |
| K252284 | eMurmur Heart AI | Csd Labs GmbH | DQD | Class II | |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co Ltd | FRO | Unclassified | |
| K252029 | Ai-Cvd | Heartlung Corporation | QIH | Class II | |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | DQA | Class II | |
| K251730 | LIA Console (542-7) | Leadoptik Inc. | NQQ | Class II | |
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | CAF | Class II | |
| K251469 | Endura™ Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. | FAD | Class II | |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik Inc. | KTI | Class II | |
| K251152 | Dblg2 | Diabeloop | QJI | Class II | |
| K251143 | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. | DXN | Class II | |
| K251077 | JOULE 1064nm System and Accessories | Sciton, Inc. | GEX | Class II | |
| K251074 | Tru Liver Health Test Panel | Truvian Health | CJE | Class II | |
| K251050 | Pectus Versa System | Gm dos Reis Industria E Comercio | HRS | Class II | |
| K251037 | Rectal Applicator | Nucletron BV | JAQ | Class II | |
| K251011 | Chiavaye Personal Moisturizer | Unipack LLC | NUC | Class II | |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U) | Sanhe LEFIS Electronics Co.,Ltd | GEX | Class II | |
| K250976 | Airbile-100 | Poskom Co., Ltd | IZL | Class II | |
| K250864 | MatriDerm pluS+ Bi-Layer | MedSkin Solutions Dr. Suwelack AG | KGN | Unclassified | |
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Medline ReNewal | PNE | Class II | |
| K232365 | Vivo 45 LS | O'Connell Regulatory Consultants, Inc. | CBK | Class II | |
| K253915 | MOVIVA® Hybrid Ablation Probe | ERBE Elektromedizin GmbH | GEI | Class II | |
| K253758 | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (MPN) | OLR | Unclassified | |
| K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K253516 | Assert-IQ (DM5100) | Abbott Medical | MXD | Class II | |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp | LRK | Class II | |
| K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. | QEW | Class II | |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) | Jiangsu Jiyuan Medical Technology Co., Ltd. | HIH | Class II | |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences LLC | DQK | Class II | |
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | PND | Class II | |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | MXK | Class II | |
| K252320 | SIMDA Abutments | Simda Co.,Ltd. | NHA | Class II | |
| K252235 | PVAD IQ Software | Ultrasight | QIH | Class II | |
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. | QVA | Class II | |
| K251915 | Amethyst HP PTA OTW 0.035 Catheter | Natec Medical Ltd | LIT | Class II | |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | PKL | Class II | |
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Olympus Medical Systems Corp. | FDX | Class II | |
| K250914 | MediAI-BA | Crescom Co., Ltd. | QIH | Class II | |
| K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics GmbH | QVP | Class II | |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | HEB | Class II | |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System | Dexcom, Inc. | QBJ | Class II | |
| K253093 | Vital™ Spinal Fixation System | Highridge Medical, LLC | NKB | Class II | |
| K252983 | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) | Shenzhen Goodwind Technology Development CO., Ltd | OHS | Class II | |
| K252922 | Neosoma Brain Mets | Neosoma, Inc. | QIH | Class II |