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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K163647 | Revolve Envi 600 Advanced Adipose System | LifeCell Corp | MUU | Class II | |
| K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corp. | LZO | Class II | |
| K161298 | ShenDa Sinuscope | Shenyang Shenda Endoscope Co., Ltd. | EOB | Class II | |
| K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) | BRH Medical Ltd | IMI | Class II | |
| K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System | Volcano Atheromed, Inc. | MCW | Class II | |
| K172061 | PRECICE UNYTE System | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K171921 | VenaCure EVLT NeverTouch Procedure Kit | Boston Scientific Corporation | GEX | Class II | |
| K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | Farus, LLC | HGM | Class II | |
| K171853 | Liver Access and Biopsy Sets | Cook Incorporated | DYB | Class II | |
| K171563 | MagnetOs Putty | Kuros Biosciences BV | MQV | Class II | |
| K171465 | Stryker Self-Punching ICONIX | Stryker Corp. | MBI | Class II | |
| K171331 | NxStage System One | NxStage Medical Inc | KDI | Class II | |
| K171299 | Fixone Biocomposite Anchor | Aju Medical Co., Ltd. | MAI | Class II | |
| K171249 | Entrada™ hip stem | Ortho Development Corp. | MEH | Class II | |
| K171173 | OrthoPediatrics Titanium PediPlates® System | Orthopediatrics Corp | HRS | Class II | |
| K171048 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) | Smiths Medical Ads, Inc. | MEA | Class II | |
| K170750 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab, Inc. | MUJ | Class II | |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small | Fisher & Paykel Healthcare, Inc. | MNT | Class II | |
| K172262 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | HRS | Class II | |
| K172227 | Endoscopic Injection Needle | Carbon Medical Technologies, Inc. | FBK | Class II | |
| K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.r.l. | NDN | Class II | |
| K172104 | Ozark(tm) Cervical Plate System | K2M, Inc | KWQ | Class II | |
| K171244 | Physiotrace | Nimbleheart, Inc. | DRX | Class II | |
| K170984 | Lg Beauty LED Mask | LG Electronics Inc. | OHS | Class II | |
| K170876 | Passport Series Patient Monitors(Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K172367 | Stryker Integrated Bipolar Cord and Tubing Sets | Stryker Corp. | GEI | Class II | |
| K172364 | EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd | LLZ | Class II | |
| K171895 | Grivamax Hair Growth System | Leana Orders, Inc. | OAP | Class II | |
| K171617 | OKI Surgical Planning Software | Wenzel Spine | LLZ | Class II | |
| K171587 | VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | FRC | Class II | |
| K171523 | Monopolar Single Use Laparoscopic Instrument | Getsch + Hiller Medizintechnik GmbH | GEI | Class II | |
| K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | FRC | Class II | |
| K171140 | Matrixx System | Nexxt Spine LLC | ODP | Class II | |
| K171041 | SilverSeal | Alliqua Biomedical, Inc. | FRO | Unclassified | |
| K170911 | NEOCERA Advanced Barrier Cream | Exeltis USA Dermatology, LLC | FRO | Unclassified | |
| K170642 | GRAVITY™ Soft Tissue Repair System | Wrightmedicaltechnologyinc | GAT | Class II | |
| K163695 | Borrelia B31 ViraChip IgM Test Kit | Viramed Biotech AG | LSR | Class II | |
| K163342 | i-STAT Hematocrit test with i-STAT Alinity System | Abbott Medical | JPI | Class II | |
| K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls | Siemens Healthcare Diagnostics Prodcts GmbH | KFF | Class II | |
| K172107 | Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System | Spineology, Inc. | NKB | Class II | |
| K171897 | Approach CTO Microwire Guide | Cook Incorporated | DQX | Class II | |
| K171526 | Zenius™, lliad™ and Kora™ Spinal Fixation Systems | Medyssey USA | NKB | Class II | |
| K171511 | RIDA GENE Norovirus GI/GII | R-Biopharm AG | PIQ | Class II | |
| K171459 | Ceribell Instant EEG Headband | Ceribell, Inc. | GXY | Class II | |
| K171452 | MAMBA and MAMBA FLEX Microcatheters | Boston Scientific Corporation | DQY | Class II | |
| K171276 | Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs | TG Medical Sdn Bhd | KGO | Class I | |
| K171225 | Sorbact Wound Dressing-Ribbon Gauze | Abigo Medical AB | FRO | Unclassified | |
| K171024 | ShockPulse-SE Lithotripsy System | Cybersonics, Inc. | FEO | Class II | |
| K163375 | INFINITY™ OCT System | Medtronic Sofamor Danek USA Inc | NKG | Class II |