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 |
|---|---|---|---|---|---|
| K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | FED | Class II | |
| K252214 | AIAS Cephalon | Metamorphosis GmbH | QIH | Class II | |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) | Olympus Medical Systems Corp. | GEI | Class II | |
| K250894 | Eminent Spine Posterior SI System | Eminent Spine | OUR | Class II | |
| K250688 | Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) | Acotec Scientific Co., Ltd. | GEI | Class II | |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. Shine Optical Co., Ltd. | LPL | Class II | |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Olympus Medical Systems Corp. | KGE | Class II | |
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) | Xemis Medical Technology (Shenzhen) Co., Ltd. | IMG | Class II | |
| K252502 | Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co.,Ltd. | INI | Class II | |
| K252140 | Heylo™ System | MEDLINE INDUSTRIES, LP - Northfield | EXB | Class I | |
| K252007 | BlineSlide | Deep Breathe, Inc. | QIH | Class II | |
| K251603 | Tigertriever 17 Ultra Revascularization Device | Rapid Medical Inc. | NRY | Class II | |
| K251565 | Wheelchair (N817) | Zhejiang Topwe Tools Manufacturing Co.,Ltd | ITI | Class II | |
| K250173 | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) | Medtronic, Inc. | BTR | Class II | |
| DEN240073 | PainChek (PainChek Adult) | PainChek Ltd. | SGB | Class II | |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) | Internacional Farmaceutica, S.A. de C.V. | GAM | Class II | |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) | Shanghai AnQing Medical Instrument Co., Ltd | FGB | Class II | |
| K252517 | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co., Ltd. | IOR | Class I | |
| K252178 | Magentiq-Colo (Me-Apds) | Magentiq Eye Ltd | QNP | Class II | |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | PKC | Class II | |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corp. | ODG | Class II | |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy System | Alleva Medical Devices | OMP | Class II | |
| K251639 | xvision Spine system | Augmedics Ltd. | SBF | Class II | |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) | Hollister Incorporated | EZD | Class II | |
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) | Jeisys Medical Incorporated | GEX | Class II | |
| K251426 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | NAY | Class II | |
| K250662 | Bunkerhill MAC | Bunkerhill Health | JAK | Class II | |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Bioscience Inc | PDJ | Class II | |
| K250039 | Hpacs | Healthhub | LLZ | Class II | |
| K250031 | Amplatzer Guidewire | Abbott Medical | DQX | Class II | |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | LRK | Class II | |
| K243968 | Revolve Surgical System | Revolve Surgical, Inc. | GCJ | Class II | |
| K242946 | Hestia (L200-a) | Senbitec Co., Ltd. | GEX | Class II | |
| DEN220077 | ProSense™ System | Icecure Medical Ltd | QXW | Class II | |
| K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) | Shenzhen Finicare Co., Ltd. | DXN | Class II | |
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | HWC | Class II | |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.r.l. | DRG | Class II | |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) | Artivion, Inc. | OHA | Unclassified | |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) | Ningbo Tianyi Medical Appliance CO., Ltd. | FJK | Class II | |
| K251398 | IPL Hair Removal Device (IPL-001, IPL-002) | Shenzhen Enmind Technology Co., Ltd. | OHT | Class II | |
| K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | LLZ | Class II | |
| K251124 | G-Bond Universal | GC America Inc. | KLE | Class II | |
| K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | BYI | Class II | |
| K250766 | LungQ 4 | Thirona BV | JAK | Class II | |
| K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) | Shenzhen Sophway Technology Co., Ltd. | GCJ | Class II | |
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) | Simergent, LLC | FKX | Class II | |
| K243152 | GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device | Applied Medical Resources Corp | HEW | Class II | |
| K252804 | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K252447 | Picosecond laser device (BMPS4) | Hebei Newangie Technology Co., Ltd | GEX | Class II |