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 |
|---|---|---|---|---|---|
| K912102 | Acs Liquid Thromboplastin | Analytical Control Systems | GJS | Class II | |
| K912095 | Magnetic Resonance Diagnostic Device | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K911971 | Modified Single Patient Use Disp. Manual Resuscit. | Medtronic, Inc. | BTM | Class II | |
| K911876 | Shiley Plexus(r) Venous Reservoir, Pvr1200 | Shiley, Inc. | DTN | Class II | |
| K911856 | Respironics Remstar with Remote and Ramp | Respironics, Inc. | BZD | Class II | |
| K911745 | Simplate Pediatric | bioMerieux, Inc. | JCA | Class II | |
| K911691 | Xyz Crank Imaging Table | Med-Tron Products, Inc. | IYZ | Class I | |
| K911565 | Custom Procedure Tray | Stryker Sustainability Solutions | KKX | Class II | |
| K911142 | Lead Terminal Pin Caps, Various Models | BIOTRONIK AG | DTD | Class II | |
| K910528 | Bipolar Sutureless Myocardial Pacing Leads | Possis Medical, Inc. | DTB | Class III | |
| K910272 | Hgm Combination Nd:yag & Solid State Green | Hgm Medical Laser Systems, Inc. | GEX | Class II | |
| K910197 | Hydrogel-Coated Urethral Catheters and Drains | C.R. Bard Inc | EZC | Class II | |
| K910195 | Bard Hydrogel-Coated Foley Catheters | C.R. Bard Inc | EZC | Class II | |
| K905677 | Jejuno-Cath Kit | Health Improvement Assoc. | FPD | Class II | |
| K905291 | Lateral Spine Determainations Dpx/dpx-L/dpx-Alpha | Lunar Corp. | KGI | Class II | |
| K903434 | Select Neuromuscular Stimulators | Medtronic, Inc. | GZI | Class II | |
| K913033 | Latex Examination Gloves | Reagent Hospital Prod., Ltd. | LYY | Class I | |
| K912868 | Group a Strep Positive and Negative Controls | Ortho-Clinical Diagnostics, Inc. | GTZ | Class I | |
| K912470 | Philips Diagnost 96 | Philips North America LLC | JAA | Class II | |
| K912338 | Tube Housing Assemblies | Comet Ltd. C/O Radiology Resources, Inc. | ITY | Class I | |
| K912269 | Landers Notched Irrigating Vitrectomy Lens Ring | Ocular Instruments, Inc. | HNH | Class I | |
| K912268 | Landers Notched Vitrectomy Lens Ring | Ocular Instruments, Inc. | HNH | Class I | |
| K912253 | Landers 3 Strut Irrigating Vitrectomy Lens Ring | Ocular Instruments, Inc. | HQE | Class II | |
| K912227 | Monark Ergometers | Quinton, Inc. | ISD | Class II | |
| K912132 | Operand Lubricating Jelly | General Medical Co. | FHX | Class II | |
| K912129 | Dobbhoff(r) Bipolar Hemostatic Probe | Biosearch Medical Products, Inc. | KNS | Class II | |
| K912120 | Urf-P2 Ureterorenofiberscope/choledochofiberscope | Olympus Corp. | FBN | Class II | |
| K912119 | Digital Sphygmomanometer Model Ub-211 and 212 | A and D Engineering, Inc. | DXN | Class II | |
| K912118 | Digital Sphygmomanometer Model Ua-833 | A and D Engineering, Inc. | DXN | Class II | |
| K912086 | Fma Translator | Normandie Group, Inc. | BXB | Class I | |
| K911649 | Mitrasheer Transplant Dressing | Polymint Industrial Co., Ltd. | MGP | Unclassified | |
| K911603 | Hemospal Kit B22 | C.G.H. Medical, Inc. | KDI | Class II | |
| K911430 | Ideia(tm) Chlamydia, Modification | Novo Nordisk Diagnostics, Ltd. | LIC | Class II | |
| K911213 | Cuffable | Biomedical Dynamics, Inc. | DXQ | Class II | |
| K911155 | Oval Cup Biopsy Forcep | Endovations | FCF | Class II | |
| K911129 | Mmg Bile Bag | Medical Technologies of Georgia | EXF | Class II | |
| K911105 | Suction/irrigation Device with Hydro-Dissection | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | |
| K911097 | Pr4 | Mortara Instrument, Inc. | DSH | Class II | |
| K911049 | Digital Sphygmoimanometer, Model Ua-830 | A and D Engineering, Inc. | DXN | Class II | |
| K910838 | Treatment Table | Tri W-G, Inc. | IXR | Class II | |
| K910558 | Terumo(r) Arterial and Venous Blood Line Set | Terumo Medical Corp. | FJK | Class II | |
| K910382 | Flexiflo Enteral Feeding Tube | Abbott Medical | KNT | Class II | |
| K905125 | Guaranty Hair Removal System | Stephens Mfg. Co. | KCX | Class I | |
| K913000 | Heart Nebulizer Pole Clamp | B & B Medical Technologies, Inc. | CAF | Class II | |
| K912988 | Latex Examination Gloves | La Glove (M) Sdn. Bhd. | LYY | Class I | |
| K912750 | Monoscopy(tm) Brand, Dual Suction/irrigation Contr | Dexide, Inc. | GCJ | Class II | |
| K912626 | Bolus Xenon Circuit | Vital Signs, Inc. | IYT | Class II | |
| K912625 | Mouth to Mask Resuscitator | Vital Signs, Inc. | BTM | Class II | |
| K912586 | Tangent IV | Fischer Imaging Corp. | IXR | Class II | |
| K912555 | Gammamed 12It High Dose Rate Remote Afterloader | Rts Technology, Inc. | JAQ | Class II |