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 |
|---|---|---|---|---|---|
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | FMF | Class II | |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. KGaA | BSZ | Class II | |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | BZD | Class II | |
| DEN250028 | DeepView AI® System | Spectralmd, Inc. | SHY | Class II | |
| K261286 | The Circadia C300 System (C300) | Circadia Health, Inc. | DRT | Class II | |
| K260717 | Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co,Ltd. | INI | Class II | |
| K260594 | IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) | Shenzhen Xiazhifeng Electronic Co., Ltd | OHT | Class II | |
| K260351 | Numen™ Helia Coil Embolization System; NumenFR™ Detachment System | MicroPort Neurotech (Shanghai) Co., Ltd. | HCG | Class II | |
| K260304 | WAVE PTA Balloon Catheter | WAVE Medical AG | LIT | Class II | |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MHX | Class II | |
| K253911 | Derma-2 | Neko Health AB | LHQ | Class I | |
| K253774 | Elos Accurate® Denture Fixation System | Elos MedTech Pinol a/S | NHA | Class II | |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | JAK | Class II | |
| K253570 | Blood Pressure Monitor (W06LT) | Shenzhen Jamr Technology Co., Ltd | DXN | Class II | |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | GEI | Class II | |
| K252717 | MAASTRO Rectal Applicator Set | Varian Medical Systems, Inc. | JAQ | Class II | |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing Set | Suzhou Zenith Vascular Scitech Limited | NRY | Class II | |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | Diadent Group International | EBF | Class II | |
| K260577 | FilmArray TF Control Panel M527 | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | OAT | Class II | |
| K260146 | Fitbone® Transport and Lengthening System | Orthofix SRL | HSB | Class II | |
| K254024 | MR5 Activ Pro | Multi Radiance Medical | NHN | Class II | |
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | PCH | Class II | |
| K253309 | SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro) | Shenzhen Soga Technology Co., Ltd. | NVK | Class II | |
| K252985 | Laport | Sejong Medical Co., Ltd. | GCJ | Class II | |
| K251270 | Taperloc® Complete Hip Stem | Zimmer GmbH | LPH | Class II | |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | GEI | Class II | |
| K260100 | MOSES Raydar™ | Boston Scientific Corporation | GEX | Class II | |
| K254109 | G-Cem Universal | GC America Inc. | EMA | Class II | |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical a/S | LLZ | Class II | |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | O&M Halyard, Inc. | FRG | Class II | |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | Hollister Incorporated | EZD | Class II | |
| K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | Ethicon, Inc | NEW | Class II | |
| K260840 | BluEX Cervical Expandable Cage System | L&K Biomed Co.,Ltd. | ODP | Class II | |
| K261289 | UNiD™ Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | QIH | Class II | |
| K261273 | Neurophet AQUA | Neurophet, Inc. | QIH | Class II | |
| K261264 | Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+ | Bausch & Lomb Incorporated | HQC | Class II | |
| K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | NKB | Class II | |
| K260771 | TruSelect™ 2.6 Microcatheter | Boston Scientific Corporation | KRA | Class II | |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | Depuy Ireland UC | KWL | Class II | |
| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc | MAX | Class II | |
| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) | Shenzhen Root Innovation Technology Co., Ltd. | BTA | Class II | |
| K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis) | Hycor Biomedical | DHB | Class II | |
| K254120 | SubtleHD-CT (1.x) | Subtle Medical Inc | QIH | Class II | |
| K254050 | Manual Tissue Removal Device | Suzhou Acuvu Medical Technology Co., Ltd. | HIH | Class II | |
| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) | Sonoscape Medical Corp. | IYN | Class II | |
| K253935 | medXion NEXUS | medXion Technologies, Inc. | OAS | Class II | |
| K253759 | cobas liat CT/NG/MG nucleic acid test | Roche Molecular Systems Inc | QEP | Class II | |
| K253756 | cobas liat CT/NG nucleic acid test | Roche Molecular Systems Inc | QEP | Class II |