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 |
|---|---|---|---|---|---|
| K781797 | Prep Tray, Preoperative Skin | Pharmaseal Div., Baxter Healthcare Corp. | OJU | Class I | |
| K781791 | Board, Disposable Control Count | Dexide, Inc. | MMK | Class II | |
| K781779 | Sani-Dent Denture Cleaner | Sandi-Dent | JER | Class I | |
| K781754 | Splint, Hoake Inflatable Air | Depuy, Inc. | KQZ | Class I | |
| K781672 | Acu-Dot | Acu-Dot Pharmaceutical Intl., Inc. | |||
| K781662 | Ria, T3 Uptake Solid Phase | BD Becton Dickinson Vacutainer Systems Preanalytic | KHQ | Class II | |
| K781656 | Nephelrate Antiserums, Igg | Antibodies, Inc. | CFN | Class II | |
| K781655 | Nephelrate Antiserums 1Ga | Antibodies, Inc. | CFN | Class II | |
| K781654 | Nephelrate Antiperums Lgm | Antibodies, Inc. | CFN | Class II | |
| K781653 | Nephelrate Antiserums C3c | Antibodies, Inc. | CZW | Class II | |
| K781522 | The Visual Speech Aid | Exeter Medical Labs, Inc. | LFA | Unclassified | |
| K781480 | Antithrombin III Assay | Dade, Baxter Travenol Diagnostics, Inc. | JBQ | Class II | |
| K781471 | Pneumatic Vitrectomy Control Unit | Helfgott Medical Instruments | HQE | Class II | |
| K781461 | Model 7320 Visual Stimulator | Life-Tech Instruments, Inc. | GWE | Class II | |
| K781222 | Accuscreen T4 | Neometrics, Inc. | CDX | Class II | |
| K781851 | Hemoglobin, Testing System | Isolab, Inc. | LCP | Class II | |
| K781670 | Stimulator, E.s.i. Neuro | Evolutionary Systems, Inc. | GZJ | Class II | |
| K781561 | Angiographic Guide Wire | Wilson Medical Instruments Co. | DQX | Class II | |
| K780819 | Glycohemoglobin-Skreen Test Kit | Eppendorf-Brinkmann, Inc. | LCP | Class II | |
| K780573 | Technique, Chromatographic, Hemoglobin | BD Becton Dickinson Vacutainer Systems Preanalytic | LCP | Class II | |
| K781863 | Device, Female Incontinence | Eschmann Bros. & Walsh, Ltd. | HHW | Class II | |
| K781847 | Latex, in-House Compounded | Arbrook Mfg. Corp. | KGO | Class I | |
| K781843 | Recorder, Holter Electrocardiogram | Hovik Corp. | DSH | Class II | |
| K781801 | Maxi-Chair | Surgical Mechanical Research, Inc. | HME | Class I | |
| K781798 | Tinnitus Masker | Starkey Laboratories, Inc. | KLW | Class II | |
| K781793 | Frame, Universal Day | B.G. Orthopedic Corp. | JEC | Class II | |
| K781753 | Tomogscanner 2 | Tomogscanner OK, Ltd. | KPS | Class II | |
| K781752 | Scanner, CT 0450 | Pfizer Medical Systems, Inc. | JAK | Class II | |
| K781736 | Disc, Coloplast Pre-Op Stoma | C.R. Bard Inc | EXA | Class I | |
| K781726 | Reagent Set, Sgpt Serum Glutamic | Medical Analysis Systems, Inc. | CKA | Class I | |
| K781725 | Reagent Set, u.v. Enzmatic Kinetic, Sgot | Medical Analysis Systems, Inc. | CIT | Class II | |
| K781724 | Nad Reduction Method, Lactate Pyrivate | Medical Analysis Systems, Inc. | CFJ | Class II | |
| K781723 | Glucose Hexokinase, Auto K | Medical Analysis Systems, Inc. | CFR | Class II | |
| K781722 | Reagent Set, Total Protein | Medical Analysis Systems, Inc. | CEK | Class II | |
| K781721 | Reagent Set, Cholesterol | Medical Analysis Systems, Inc. | CHH | Class I | |
| K781720 | Hbdh Enzyme Kinetic Reagent Set | Medical Analysis Systems, Inc. | JMK | Class I | |
| K781719 | Cpk Reagent Set, Nad Reduction | Medical Analysis Systems, Inc. | CGS | Class II | |
| K781718 | Alp Reagent Set, Alkaline Phosphatase | Medical Analysis Systems, Inc. | CJE | Class II | |
| K781700 | Ionotphoretic Applicator | Mcghan Medical Corp. | KTB | Class II | |
| K781698 | Examiner 10 | American Sterilizer Co. | HJE | Class II | |
| K781696 | Copper-Trap | Olympic Medical Corp. | CAH | Class II | |
| K781668 | Gamma Radiation Sterilization Precedure | Cutter Laboratories, Inc. | KYJ | Class II | |
| K781667 | Amplaid Mark 4 and Mark 5 | Amplaid USA, Inc. | GWJ | Class II | |
| K781539 | ISO-Care Kit | Nice-Pak Products, LLC | HMP | Class I | |
| K781433 | Akron Male External Catheter | Latex Ind., Inc. | KNX | Class II | |
| K781239 | Myo-Stim | Med General | IPF | Class II | |
| K780852 | Clinitex Vis-X Aspirating Accessory | Varian Assoc., Inc. | HKP | Class II | |
| K781695 | Lube-Lok | Olympic Medical Corp. | CBH | Class I | |
| K781600 | Misty-Ox Prefilled Humidifier, Disp. | Davco | BTT | Class II | |
| K781494 | EEG Lead Assembly | Graphic Controls Corp. | GXY | Class II |