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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K143256 | SMR Modular Glenoid | Lima Corporate S.p.A. | KWS | Class II | |
| K142954 | PTA 14 Balloon Dilatation Catheter OTW | Texasmedical Technologies, Inc. | LIT | Class II | |
| K142586 | Captiva Spine FuselOX Cervical IBF System | CAPTIVA SPINE, Inc. | ODP | Class II | |
| K142494 | ViMove | Dorsavi Ltd | IKN | Class II | |
| K142355 | Vaginal Tactile Imager | Advanced Tactile Imaging, Inc. | HIR | Class II | |
| K141874 | Uriscan Optima | YD Diagnostics | KQO | Class I | |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls | Lin-Zhi International Inc | LDJ | Class II | |
| K151134 | 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) | JVCKENWOOD Corporation | PGY | Class II | |
| K151110 | Intersept Filtered Cardiotomy Reservoir | Medtronic, Inc. | DTN | Class II | |
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff | MEDLINE INDUSTRIES, LP - Northfield | OCY | Class II | |
| K150707 | IntelePACS | Intelerad Medical Systems Incorporated | LLZ | Class II | |
| K150627 | Rapid Aid Instant Disposable Infant Heel Warmer | Rapid Aid Corp. | MPO | Class I | |
| K150511 | Coating Material | Sun Medical Co., Ltd. | EBI | Class II | |
| K150282 | Shaser Skin Beauty Intense Pulsed Light System Family for Acne | Shaser, Inc. | ONF | Class II | |
| K150137 | SpiroThor | Cohero Health, LLC | BZG | Class II | |
| K150117 | Medtronic Patient Asistant | Medtronic, Inc. | DSI | Class II | |
| K143198 | Synapse Transcutaneous Electrical Stimulation Device | Synapse Electroceutical Limited | GZJ | Class II | |
| K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | HWC | Class II | |
| K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System | Volcano Atheromed, Inc. | MCW | Class II | |
| K150454 | Acryfree Denture Base Material and Biosens Denture Base Material | Perflex Ltd | EBI | Class II | |
| K150420 | Centricity Universal Viewer | GE Healthcare | LLZ | Class II | |
| K150269 | Ballancer 505 System, Model 1201-AC | MEGO AFEK AC Ltd. | IRP | Class II | |
| K150091 | Versatex Monofilament Mesh | Sofradim Production | FTL | Class II | |
| K143304 | Sickbay Clinical Platform | Medical Informatics Corp. | MWI | Class II | |
| K143118 | Human Microalbumin kit for use on SPAPLUS | The Binding Site Group Ltd. | DCF | Class II | |
| K142971 | AMT Bridle - Nasal Tube Retention System | Applied Medical Technology Inc | KNT | Class II | |
| K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra Inc. | QEW | Class II | |
| K142549 | Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste | J.C.E.C. Company, Inc. (Doing Business AS Fountain Health CA | LFD | Unclassified | |
| K141902 | Lagis Endoscopic Instruments Disposable Grasper | Lagis Enterprises Co, Ltd. | GCJ | Class II | |
| K140386 | Lumina 24 | Rogers Sciences, Inc. | GEX | Class II | |
| K151222 | Cautery Tip Cleaner | Key Surgical, LLC | GEI | Class II | |
| K151102 | Bausch + Lomb Injector System | Bausch & Lomb Incorporated | MSS | Class I | |
| K151076 | MicroTaper Needle Introducer Set | Summit Access, LLC | DRE | Class II | |
| K150941 | Somnowell Mandibular Advancement Appliance (MAA) | Somnowell, Ltd. | LRK | Class II | |
| K150801 | Stryker Maestro Air Motors | Stryker Corp. | HBB | Class II | |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | MicroAire Surgical Instruments, LLC | MUU | Class II | |
| K150628 | VentriPoint Medical System | Ventripoint, Inc. | IYN | Class II | |
| K150600 | Response 5.5/6.0 Spine System | Orthopediatrics Corp | NKB | Class II | |
| K150563 | Marrow Cellution Bone Marrow Aspiration Needle | Ranfac Corp. | KNW | Class II | |
| K150471 | CalcaNail Orthopedic Arthrodesis Nail | Fournitures Hospitalieres Industrie | HSB | Class II | |
| K150463 | CalcaNail Orthopedic Nail | Fournitures Hospitalieres Industrie | HSB | Class II | |
| K150139 | Rachel's Remedy | Rachel'S Remedies, LLC | IMA | Class I | |
| K150069 | Fine Structure Analysis(fineSA) | Acuitas Medical, Ltd. | LLZ | Class II | |
| K143740 | Battalion Universal Spacer System | Alphatec Spine, Inc. | MAX | Class II | |
| K143683 | APEX-DL Spine System | Spinecraft LLC | NKB | Class II | |
| K142806 | DualCap | Catheter Connections, Inc. | QBP | Class II | |
| K142666 | Scrambler Therapy MC-5 A Device | Delta International Services & Logistics S.R.L | GZJ | Class II | |
| K142648 | SPINEDESIGN Spine Surgery Planning (Software Application) | Medtronic Sofamor Danek USA Inc | LLZ | Class II | |
| K142458 | Penumbra System ACE | Penumbra Inc. | NRY | Class II | |
| K142385 | Whisper Pump System | Wound RX Medical, LLC | OMP | Class II |