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 |
|---|---|---|---|---|---|
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd | ITX | Class II | |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | Stryker Sustainability Solutions | NLQ | Unclassified | |
| K241600 | Dermablate | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K241591 | Blue Eye | The Standard Co., Ltd. | PLL | Class II | |
| K241577 | Iconix® Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K241508 | SKOUT® system | Iterative Scopes, Inc. | QNP | Class II | |
| K241371 | Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500) | Olympus Medical Systems Corp. | FET | Class II | |
| K241284 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | |
| K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO, Ltd. | HWC | Class II | |
| K241129 | Upper Arm Electronic Blood Pressure Monitor | ShenZhen GoodlyMed Technology Co.,Ltd. | DXN | Class II | |
| K240996 | Access Thyroglobulin Antibody II | Siemens Healthcare Diagnostics Inc. | JNL | Class II | |
| K240987 | Access sTfR | Siemens Healthcare Diagnostics Inc. | DDG | Class II | |
| K240946 | Gastric Alimetry | Alimetry Ltd | MYE | Class II | |
| K240052 | Disposable Enteral Feeding Sets | Beijing L&Z Medical Technology Development Co., Ltd. | PIF | Class II | |
| K240009 | iQFlex Pro | First Source Inc | IZL | Class II | |
| K233574 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc | JWJ | Class II | |
| K241622 | Extended Reservoir; MiniMed Reservoir | Medtronic, Inc. | LZG | Class II | |
| K241574 | iFuse TORQ® Implant System | SI-Bone, Inc. | OUR | Class II | |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences LLC | DXE | Class II | |
| K241300 | ViewPoint 6 | GE Healthcare | LLZ | Class II | |
| K240930 | Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue | SRI Trang Gloves (Thailand) Public Company Limited. | LZA | Class I | |
| K240915 | ZIEN IO Intraosseous Access System | Zien Medical Technologies LLC | FMI | Class II | |
| K240863 | Freedom® Total Knee System | Maxx Orthopedics Inc. | JWH | Class II | |
| K240736 | SMART Bun-Yo-Matic X-Ray | Disior Oy | QIH | Class II | |
| K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) | Shenzhen Micro Electric Intelligence Co., Ltd. | ELC | Class II | |
| K240555 | Tyto Insights for Crackles Detection | Tyto Care Inc. | PHZ | Class II | |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing Set | Balt USA, LLC | NRY | Class II | |
| K234074 | Next Generation Access Catheter | Balt USA, LLC | QJP | Class II | |
| K233626 | AOS Marker Seeds (SMG0242-025) | Alpha Omega Services Inc | JAQ | Class II | |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | Philips Medizin Systeme Boeblingen GmbH | HGM | Class II | |
| K233415 | DELTAWAVE Nasal Pillows System | Remsleep Holdings Inc | BZD | Class II | |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | |
| DEN240013 | MagDI System | GT Metabolic Solutions, Inc. | SAH | Class II | |
| K241639 | Single-use Video Ureterorenoscope (SVU-220US) | Huger Medical Instrument Co., Ltd. | FGB | Class II | |
| K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500) | Boston Scientific Corporation | FGB | Class II | |
| K241202 | Electric nasal aspirator (HTD2601US) | Hetaida Technology Co., Ltd. | BTA | Class II | |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | DENT4YOU AG | ELC | Class II | |
| K240572 | Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’ (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4” (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5” (165mm) electrode) (VSMEN6) | Medtronic, Inc. | GEI | Class II | |
| K240536 | Wearable Breast Pump (Model S32) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K240477 | Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens | St. Shine Optical Co., Ltd. | LPL | Class II | |
| K240353 | Hyper Insight - ICH | Sk, Inc. | QAS | Class II | |
| K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | OBO | Class II | |
| K240070 | Profound Matrix | Candela Corporation | GEI | Class II | |
| K234061 | StarFormer | Fotona d.o.o. | KPI | Class II | |
| K233908 | cNeuro cDAT | Combinostics | LLZ | Class II | |
| K233477 | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) | Shandong Wego Ruisheng Medical Device Co.,Ltd | MQL | Class II | |
| K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | Shenzhen AOJ Medical Technology Co., Ltd. | DQA | Class II | |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | |
| K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters | Innovative Health, LLC. | NLI | Class II | |
| DEN240007 | BioHealx Anal Fistula Device | Signum Surgical Limited | QML | Class II |