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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K072946 | Hybresis Iontophoresis Drug Delivery System | Empi | EGJ | Class II | |
| K072912 | Sopro 225 Dual Halogen Light Source | Sopro | GCJ | Class II | |
| K072874 | Lbs-127-16 Breast Array Coil | Invivo Corporation | MOS | Class II | |
| K072873 | Lbs-63-16 Breast Array Coil | Invivo Corporation | MOS | Class II | |
| K072755 | Galemed CPAP Mask | Galemed Corp. | BZD | Class II | |
| K072698 | Confidant 2.5 | Confidant, Inc. | DRG | Class II | |
| K072695 | Vitek 2 Gram Positive Tigecycline | bioMerieux, Inc. | LON | Class II | |
| K072643 | Crystaleye Spectrophotometer/crystaleye Basic Set, Model Ce100-Dc/us | Olympus Corp. | KZN | Class II | |
| K072604 | Duo Temp | Coltene /Whaledent AG | EMA | Class II | |
| K072522 | Thermoform Sheet Materials and Accessories | Dentsply International, Inc. | MQC | Unclassified | |
| K072483 | Atlantis Abutment in Zirconia for 3I Certain Microamini Implants, Gemini Abutment in Zirconia for Astra Implants | Atlantis Components, Inc. | NHA | Class II | |
| K072470 | Bioelast 5-0 Suture, Model 500100 | Entrigue Surgical, Inc. | NWJ | Class II | |
| K072048 | Lumacare Model Lc-122M Non-Coherent Light Source and Model Lum-P Fibre Optic Probe | Lynton Lasers Limited | ILY | Class II | |
| K071921 | Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial Screws) | Innovasis, Inc | NKB | Class II | |
| K071161 | Endosseous Dental Implant System | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K071127 | Flexible Hysteroscope with Endosheath System | Cogentix Medical, Inc. | HIH | Class II | |
| K070690 | The Life Vessel | Cottonwood Vessel Corporation | ILY | Class II | |
| K073053 | Colpo-Master | United Products & Instruments, Inc. | HEX | Class II | |
| K072933 | Spi Contact Platform O 4.0 Mm | Thommen Medical AG | DZE | Class II | |
| K072747 | Unidus Magnum Male Latex Condom | Unidus Corp. | HIS | Class II | |
| K072659 | Rad Vision, Models E and EU | Almana Medical Imaging | KPR | Class II | |
| K072593 | A-Plus Arterial Pulse Waveform Analysis System and Pc Software | Healthstats International Pte., Ltd. | DXN | Class II | |
| K072306 | Bioxtra Moisturizing Gel | Bio-X Healthcare S.A. | LFD | Unclassified | |
| K072092 | Xpod/xmap Nerve Stimulator | Xavant Technology (Pty) Ltd | BXN | Class II | |
| K071657 | Tru Flu | Meridian Bioscience Inc | PSZ | Class II | |
| K070968 | Choy Compression Frame | Choy Medical Technologies, Inc. | LNH | Class II | |
| K070375 | Earlysense Es-16 System | Earlysense, Ltd. | BZQ | Class II | |
| K072984 | Saturn 9000-550 | New Medical Co., Ltd. | MQB | Class II | |
| K072769 | Angiojet Ultra; Xmi (105041), Xvg (105042) and Spiroflex (106553) Thrombectomy Sets | Possis Medical, Inc. | QEZ | Class II | |
| K072554 | Access and Rotamax Fiber Optic High Speed Dental Handpieces | Sable Industries, Inc. | EFB | Class I | |
| K072549 | Titanium Powerport Isp Implanted Port with 6 Fr Chronoflex Polyurethane Catheter | C.R. Bard Inc | LJT | Class II | |
| K072371 | Odyssey Workstation | Stereotaxis Inc | DXX | Class II | |
| K071895 | Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator | STERIS Corporation | JOJ | Class II | |
| K063733 | Resolve Biliary Drainage Catheter | Merit Medical Systems, Inc. | FGE | Class II | |
| K073056 | Digital Radiography System, Model: Qxr-9 | Vieworks Co., Ltd. | MQB | Class II | |
| K072983 | Saturn 9000-750 | New Medical Co., Ltd. | MQB | Class II | |
| K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | ITX | Class II | |
| K072033 | Otodynamics Otoport | Otodynamics, Ltd. | EWO | Class II | |
| K071224 | Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator | Siemens Healthcare Diagnostics Inc. | CDD | Class II | |
| K073025 | Vascutrak II Pta Dilatation Catheter | Thermopeutix, Inc. dba Ymed, Inc. | PNO | Class II | |
| K073016 | Trojan Thintensity Brand Male Latex Condom Lubricated with Ultrasmooth and Warm Sensations Lubricant | Church & Dwight Co., Inc. | HIS | Class II | |
| K072916 | Trilogy System with Rapidarc | Varian Medical Systems, Inc. | IYE | Class II | |
| K072808 | Speedicath Compact | MEDLINE INDUSTRIES, LP - Northfield | GBM | Class II | |
| K072748 | Modification to: Diamondback 360 Orbital Atherectomy System | Cardiovascular Systems Incorporated | MCW | Class II | |
| K072724 | Cxi Support Catheter | Cook Inc. | KRA | Class II | |
| K072479 | Flexite Supreme, Flexite Plus, Flexite M.p., Northern and Flexite Pro-Guard | Rapid Injection Systems Corp. | EBI | Class II | |
| K072419 | Advantiv Safety i.v. Catheter | Abbott Medical | FOZ | Class II | |
| K072378 | Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models Ar-1625, Ar-1626 | Arthrex GmbH | FRO | Unclassified | |
| K072250 | Supercable Grip and Plate System | Kinamed Inc | KTT | Class II | |
| K072248 | Viapeel Peelable Introducer | Greatbatch Medical | DYB | Class II |