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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K860180 | Model 446 & 447 Mouth to Mask Resuscitator | Life Support Products, Inc. | BTM | Class II | |
| K860129 | ISO-Mammo | Philips North America LLC | IZH | Class II | |
| K860031 | Gen Diagnostics' Imipenem 10 Mcg Susceptibity Disk | bioMerieux, Inc. | JTT | Class II | |
| K855207 | Imipenem 10 Mcg Sensitivity Discs | Difco Laboratories, Inc. | JTT | Class II | |
| K855136 | Flexor Flexible Roane Tip Endodontic File | Union Broach, Div. Moyco Industries, Inc. | EKS | Class I | |
| K855113 | Floss Holder (Plastic) | Pacific Union Dental, Inc. | JES | Class I | |
| K855112 | Disposable 3In Check Bite Impression Trays | Pacific Union Dental, Inc. | ELW | Class II | |
| K855111 | Disposable Plastic Dent Impression Trays 9 Styles | Pacific Union Dental, Inc. | ELW | Class II | |
| K855106 | Imipenem 10 Mcg Sensi-Disc,cat. # 31644/31645 | BD Becton Dickinson Vacutainer Systems Preanalytic | JTT | Class II | |
| K855071 | Imipenem Susceptibility Powder | Merck, Sharp & Dohme | JTT | Class II | |
| K855037 | Tru-Color | Veritas Dental Co., Inc. | EIH | Class II | |
| K854749 | Startanius Dental Implant System | Park Dental Research Corp | DZE | Class II | |
| K854741 | X-Range 65 | Alpine Dental Equipment Co. | EHD | Class II | |
| K854738 | Spartan Solder | Williams Gold Refining Co., Inc. | EJH | Class II | |
| K854733 | Api 20 Ec (Enterobacteriaceae)(identification Kit) | Dms Products, Inc. | JSS | Class I | |
| K854721 | Nemectrodyn Model 2 & Endovac 2 | Nemectron Medical, Inc. | LIH | Class II | |
| K854702 | Plastic Mounting Rings | Almore Intl., Inc. | EJP | Class I | |
| K854701 | Retract-a-Cord | Almore Intl., Inc. | JES | Class I | |
| K854697 | Tubing Handpiece Replacement | Almore Intl., Inc. | EFB | Class I | |
| K854646 | Vega Dental Operating Light | Alpine Dental Equipment Co. | EBA | Class I | |
| K854203 | Tec 2720 Mamex Dc Mag | Tecnomed, Inc. | IZH | Class II | |
| K854110 | Keithley Model 75100 & 75200 | Keithley Instruments, Inc. | KPR | Class II | |
| K854015 | Fs Test Kit | American Bioproducts Co. | JBN | Class II | |
| K860607 | Markoptic Improved Arthroscope | Markoptic | HRX | Class II | |
| K860598 | Modified Protective Garment for Incontinents | Procter & Gamble Mfg. Co. | EYQ | Class I | |
| K860567 | Nordic Sun Home Tanning Unit | Nordic Sun Corporation of America | FTC | Class II | |
| K860566 | Nordic Sun 24 Lamp Tanning Bed | Nordic Sun Corporation of America | FTC | Class II | |
| K860542 | Tandem Icon II Hcg Immunoenzymetric Assay Kit | Hybritech, Inc. | JHI | Class II | |
| K860509 | Sunbed/canopy, Models Gti 24N,30r,30re & 37Re | Ecomatic GmbH, Frankfurt, F.R.G. | FTC | Class II | |
| K860490 | Medix Visual Hcg - M Hcg Enzyme Immunoassay | Medix Biotech, Inc. | JHI | Class II | |
| K860476 | Acid Phosphatase Reagent Set | Sterling Diagnostics, Inc. | CKE | Class II | |
| K860286 | Il Test Phenytoin | Allied Instrumentation Laboratory | DIP | Class II | |
| K860266 | Ellik Evacuator | R. J. Ltd., Ind. | KQT | Class II | |
| K860263 | Castle 7538 Floor Loading Washer | Castle Co. | LDS | Class II | |
| K860221 | Encore Prolactin Reagent | Hybritech, Inc. | CFT | Class I | |
| K860057 | Abl330 Acid Base Laboratory | Radiometer America, Inc | CHL | Class II | |
| K860014 | Systems Plus | United Surgical LLC | HQE | Class II | |
| K855188 | Cpk (UV) Reagent Kit | Technostics Intl. | JHS | Class II | |
| K855079 | Neonatal Bilirubin(nbil) Test Pack 67661/95 | Em Diagnostic Systems, Inc. | CIG | Class II | |
| K855050 | Storz E9040 & E9046 Diamond Knives | Storz Instrument Co. | HNN | Class I | |
| K854935 | Link Metal-Backed Acetabular Cups | Link America, Inc. | JDL | Class III | |
| K854869 | Intraocular Forceps & Scissors | Mira, Inc. | HNR | Class I | |
| K854723 | Skd Electrochemical System (Ecs) | Smithkline Diagnostics, Inc. | CEM | Class II | |
| K854336 | Monofixateur | Ortopedia GmbH | HWC | Class II | |
| K860658 | Kultsure (Catalogue No. M250) | Ncs Diagnostics, Inc. | JSM | Class I | |
| K860657 | Kultsure (Catalogue No. M240) | Ncs Diagnostics, Inc. | JSM | Class I | |
| K860656 | Kultsure (Catalogue No. M210) | Ncs Diagnostics, Inc. | JSM | Class I | |
| K860582 | Tbi Needle | Hobbs Medical, Inc. | GAA | Class I | |
| K860529 | Rotalex | Orion Corp. | LIQ | Class I | |
| K860515 | Dual Lumen Needle (Product Change) | Quinton, Inc. | LBW | Class II |