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 |
|---|---|---|---|---|---|
| K232764 | Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Eco Medi Glove Sdn Bhd | LZA | Class I | |
| K232171 | Purema® H Hemoconcentrator (EtO Sterilized) | Tecnoideal America | KDI | Class II | |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K233960 | INNOVERSE Spinal System | Innosys Co., Ltd. | NKB | Class II | |
| K233897 | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) | Shenzhen Beacon Display Technology Co., Ltd. | PGY | Class II | |
| K233593 | MAGEC Spinal Bracing and Distraction System | Nuvasive Specialized Orthopedics, Incorporated | PGN | Class II | |
| K233416 | Cryojet Plus (SHE-ACP001-1) | Beijing Sano Laser S&T Development Co, Ltd. | GEX | Class II | |
| K233221 | Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Metro Optics of Austin, Inc. | LPL | Class II | |
| K233115 | Hawkeye Control Unit with Eyas Endoscope | E Surgical, LLC | HRX | Class II | |
| K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Buhlmann Laboratories AG | NXO | Class II | |
| DEN230041 | Sleep Apnea Feature | Samsung Electronics Co., Ltd. | QZW | Class II | |
| K240099 | Ziehm Vision RFD | Ziehm Imaging GmbH | OWB | Class II | |
| K234075 | Flow-Nail | Flow-Fx, LLC | HSB | Class II | |
| K234013 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ | Bone Solutions, Inc. | MQV | Class II | |
| K233895 | EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA); OptiSite Arterial Perfusion Cannulae (OPTI16, OPTI18, OPTI20 and OPTI22); EndoReturn Arterial Cannulae (ER21B and ER23B); | Edwards Lifesciences LLC | DWF | Class II | |
| K233600 | Smart Fit Knee 3.0T | Philips Healthcare (Suzhou) Co., Ltd. | MOS | Class II | |
| K233174 | FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream | Assure Tech. (Hangzhou) Co., Ltd. | LCX | Class II | |
| K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | MHX | Class II | |
| K232379 | PREVENT Kit | Clear Choice Therapeutics, Inc. | OMP | Class II | |
| K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Viz. Ai, Inc. | QIH | Class II | |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | Integra LifeSciences Production Corporation | GWM | Class II | |
| K232210 | X-trodes System M | X-Trodes | GWL | Class II | |
| K240030 | Indigo® Aspiration System - Lightning® Flash | Penumbra Inc. | QEW | Class II | |
| K233855 | AllPEP | Enchant Tek Co. Ltd. | BWF | Class II | |
| K233756 | Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) | Rhein Laser Technologies Co., Ltd. | GEX | Class II | |
| K233531 | OIC FLEX-FIX™ System | The Orthopaedic Implant Company | HTN | Class II | |
| K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | FED | Class II | |
| K233143 | PiXel8-Reveal | Rohrer Aesthetics, Inc. | GEX | Class II | |
| K231625 | VitalDetect | Wellvii Inc | FLL | Class II | |
| K231534 | 5008X Hemodialysis System | Fresenius Medical Care | KDI | Class II | |
| K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | Becton Dickinson & Co | JKA | Class II | |
| K231325 | Corplex P / Theracor P / Allacor P | Stimlabs, LLC | KGN | Unclassified | |
| K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | MQC | Unclassified | |
| K240018 | WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation | DQY | Class II | |
| K233804 | Resonic Rapid Acoustic Pulse Device | Zeltiq Aesthetics Inc | GEX | Class II | |
| K233183 | Surgical Gown (40083) | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. | FYA | Class II | |
| K232949 | Kelowna GYN and Crook Prostate Templates | Varian Medical Systems, Inc. | JAQ | Class II | |
| K232339 | Augmented Reality Application | Sira Medical, Inc. | LLZ | Class II | |
| K232165 | Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles | Berpu Medical Technology Co., Ltd. | FMI | Class II | |
| K232007 | CAAS MR Solutions | PIE Medical Imaging B.V. | LLZ | Class II | |
| K230657 | Btl-99-Oc | BTL Industries, Inc | QCI | Class II | |
| K240025 | Clearblue® Early Detection Pregnancy Test | SPD Swiss Precision Diagnostics GmbH | LCX | Class II | |
| K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer | CIRCA Scientific, Inc. | DYB | Class II | |
| K233140 | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) | Hygea Medical Technology Co., Ltd. | NEY | Class II | |
| K232678 | Digital Thermometer, Model T28, T28L | Guangdong Genial Technology Co., Ltd. | FLL | Class II | |
| K231396 | CEPHX- Cephalometric Analysis Software | Orca Dental AI | LLZ | Class II | |
| K214115 | MightySat -OTC | Masimo Corporation | OLK | Class II | |
| DEN210035 | “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” | Hologic, Inc. | QYV | Class II | |
| K240020 | Ziehm Vision FD | Ziehm Imaging GmbH | OWB | Class II | |
| K234140 | VIVA combo RF System (VIVA combo RF System) | Starmed Co.,Ltd | GEI | Class II |