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 |
|---|---|---|---|---|---|
| K231185 | MapRT | Vision Rt Inc | IYE | Class II | |
| K231153 | Neuhat Hair Growth System; ibeauty.com Laser Cap | Nature, Inc.redible, Inc. | OAP | Class II | |
| K231117 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC, A Bioventus Company | LFL | Unclassified | |
| K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | Spineart SA | PML | Class II | |
| K230518 | HydraDose Vaginal Suppositories | MD Labs, LLC | NUC | Class II | |
| K230410 | DD medical polymers (PMMA) | Dental Direkt GmbH | EBI | Class II | |
| K230369 | EUROPA™ Navigated Instruments | Mirus, LLC | OLO | Class II | |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K230276 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | DZJ | Class II | |
| K230160 | Vinno G86,vinno G86e,vinno G65,vinno G65p,vinno G65e,vinno G65d,vinno M86, Vinno M86e,vinno G90,vinno G90e | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | GAT | Class II | |
| K223638 | Neodent Implant System - Helix Short Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory Co. | QLU | Class II | |
| K223159 | Radixact Treatment Delivery System | Accuray Incorporated | IYE | Class II | |
| K223048 | Medisystem Pacs | Medilab Manutencao E Sitemas Ltda | LLZ | Class II | |
| K223019 | sam 2.0 Long Ultrasound Device | ZetrOZ Systems | PFW | Class II | |
| K223013 | AccurECG Analysis System | Accurkardia Inc. | DPS | Class II | |
| K222982 | Virtus Metabolic Monitor | Virtus Technology ApS | BTY | Class II | |
| K222969 | FERTI-LILY Conception Cup | Rosesta Medical BV | HDR | Class II | |
| K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | Encore Medical, LP | KWS | Class II | |
| K222323 | Black Diamond | Elevate Oral Care, LLC | PHR | Class II | |
| K221827 | Mais Central Venous Catheter | Saudi Mais Co. for Medical Products | FOZ | Class II | |
| K221411 | Surflo Winged Infusion Set | Terumo Medical Products (Hangzhou) Co., Ltd. | FPA | Class II | |
| K220955 | Hudson RCI Variable concentration Large Volume Nebulizer (1770) | Medline Industires, Inc. | CAF | Class II | |
| K231202 | QuickRayPRO | Denterprise International, Inc. | MUH | Class II | |
| K231131 | Diode Laser Body Sculpture Systems | Shanghai Bele Medical Technology Co.,Ltd | PKT | Class II | |
| K230904 | Arthrex Virtual Implant Positioning (VIP) System | Arthrex GmbH | QHE | Class II | |
| K230599 | TargetCool™ | Recensmedical Inc. | GEH | Class II | |
| K230497 | Bladder AI (AIBV01) | Exo, Inc. | QIH | Class II | |
| K230444 | Talee, Talee PostOp | Invent Medical USA, LLC | MVA | Class II | |
| K230322 | SelectFlex Neurovascular Access System Family | Q'apel Medical, Inc. | QJP | Class II | |
| K223871 | Miria Skin Treatment System | Avava, Inc. | ONG | Class II | |
| K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) | Zhuhai Pusen Medical Technology Co., Ltd. | FBN | Class II | |
| K223558 | CUVIS-spine | CUREXO, Inc. | OLO | Class II | |
| K223379 | Portable Oxygen Concentrator (Model: P2-E7, P2-E) | Qingdao Kingon Medical Science and Technology Co.,Ltd | CAW | Class II | |
| K223083 | Straumann SLActive labeling changes | Straumann USA, LLC | DZE | Class II | |
| K222932 | INVOcell Intravaginal Culture System | Invo Bioscience | OYO | Class II | |
| K231533 | Habib EndoHPB | Boston Scientific Corporation | KNS | Class II | |
| K231489 | Sturdy Autoclave Super Microm | Sturdy Industrial Co., Ltd. | FLE | Class II | |
| K231485 | iLet® ACE Pump | Beta Bionics, Inc. | QFG | Class II | |
| K231469 | PAXgene® Blood DNA Tube | Preanalytix GmbH | PJE | Class II | |
| K231467 | 1417Wce, 1417Wce-Hr, 1417Wce-Hs, 1417Wce-Gf | Rayence Co., Ltd. | MQB | Class II | |
| K231212 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical, Inc. | GEI | Class II | |
| K231031 | ACL TOP Family 70 Series | Instrumentation Laboratory Co. | GKP | Class II | |
| K230886 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | Stryker Corp. | GCJ | Class II | |
| K230506 | PureLift Pro Edition | Xtreem Pulse | NFO | Class II | |
| K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) | Centerline Biomedical | DQK | Class II | |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) | Cardinal Health200, LLC | MEG | Class II | |
| K223248 | Tablo® Hemodialysis System | Outset Medical, Inc. | KDI | Class II | |
| K223033 | Tixel® 2 System | Novoxel Inc. | GEI | Class II |