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 |
|---|---|---|---|---|---|
| K970963 | Targis Alloy #7 | Ivoclar North America, Inc. | EJT | Class II | |
| K970841 | Imtec/titanium Mesh | Imtec Corp. | JEY | Class II | |
| K970743 | Bcw Power Advantage Wheelchair | Wheelchairs of Kansas | ITI | Class II | |
| K970549 | Titanium Alloy Bone Screws | Aesculap Inc | HWC | Class II | |
| K970503 | Depuy Ace Trochanteric Side Plate | Depuy Ace Medical Co. | HRS | Class II | |
| K970501 | Pegged Acetabular Component | Zimmer GmbH | LPH | Class II | |
| K970500 | 3M Sustel Dental System | 3M Company | EBF | Class II | |
| K970498 | Natural-Knee II Revision Femoral Spacer Lugs | Intermedics Orthopedics | JWH | Class II | |
| K970493 | Hyfrecator 2000 | Aspen Labs | GEI | Class II | |
| K970448 | Pcm 2000; Isolair Apr Model 2735 | Tecnol Medical Products, Inc. | MSH | Class II | |
| K970447 | Implex Bipolar Hip System | Implex Corp. | KWY | Class II | |
| K970442 | Target Vital-Port Vascular Access System | Med Institute, Inc. | LJT | Class II | |
| K970423 | Innovasive Roclet Bone Tunnel Augmentation Device | Innovasive Devices, Inc. | MBI | Class II | |
| K970378 | Stryker 2115 Replacement Battery (2115) | Implant Resource Inc | KIJ | Class I | |
| K970353 | Aura Tek Fdp | Perimmune, Inc. | MMW | Class II | |
| K965205 | Tefgen - Ls | American Custom Medical, Inc. | NPK | Class II | |
| K965199 | Tuna 5 Catheter | Vidamed, Inc. | GEI | Class II | |
| K964208 | Md-1A Galvanic Unit | R. A. Fischer Co. Corp. | EGJ | Class II | |
| K962788 | Clinidyne Rotational Therapy Mattress System | Gaymar Industries, Inc. | IKZ | Class II | |
| K960951 | Permobil Chairman L/cs 8 | Permobil, AB | ITI | Class II | |
| K955592 | Cobe Centrysystem 14 Pes Hemodialyzers | Cobe Renal Care, Inc. | KDI | Class II | |
| K970429 | Bioscope Sd TENS, Arista Sd Plus, Ap-102080T | Apex Medical, Inc. | GZJ | Class II | |
| K970418 | Pmt Accessory Depthalon Electrode Anchor Bolt (2103-23-Xx) | PMT Corp. | GZL | Class II | |
| K970345 | Alignment Instrument | Richard Wolf Medical Instruments Corp. | HSZ | Class I | |
| K970204 | Bk-a; Bk-B; Bk-Is Sealing Cap | BIOTRONIK AG | DTD | Class II | |
| K964695 | Immage Immunochemistry System Albumin (Alb) Reagent | Beckman Instruments, Inc. | DCF | Class II | |
| K964642 | Medrad Disposable Syringes | Medrad, Inc. | DXT | Class II | |
| K971142 | Adventurer | T.E.S., Ltd. | IOR | Class I | |
| K971141 | Ft4 Method for the Dimension Rxl Clinical Chemistry System | Dade Chemistry Systems, Inc. | CEC | Class II | |
| K971128 | Cap-35B Iii/cine 275 | Jamieson Film Co. | IXR | Class II | |
| K970623 | Immerge Image Correlation | Surgical Navigation Technologies, Inc. | LLZ | Class II | |
| K964400 | Alphatec External Fixation System | Alphatec Spine, Inc. | KTT | Class II | |
| K964119 | Wallstent Transhepatic Biliary Endoprosthesis | Boston Scientific Corporation | FGE | Class II | |
| K963916 | Immulite Cannabinoids | Siemens Healthcare Diagnostics Inc. | LDJ | Class II | |
| K963601 | Model 1920 Waste Gas Scavenger | G. Dundas Co. | CBN | Class II | |
| K963385 | Quickie Power Wheelchairs P200 Series | Quickie Designs, Inc. | ITI | Class II | |
| K963382 | Quickie P100 Series | Quickie Designs, Inc. | ITI | Class II | |
| K963381 | Quickie P300 Series | Quickie Designs, Inc. | ITI | Class II | |
| K955026 | As/3 Nmt Module | Datex Medical Instrumentation, Inc. | KOI | Class II | |
| K971122 | Acculine Pregnancy Test | Genix Biotek, Inc. | JHI | Class II | |
| K970820 | Etest Sparfloxacin | Ab Biodisk | JWY | Class II | |
| K970607 | Universal Reagent Factor VII Deficient Plasma | Universal Reagents, Inc. | GJT | Class II | |
| K970593 | Universal Reagent Factor VIII Deficient Plasma | Universal Reagents, Inc. | GJT | Class II | |
| K970380 | F.a.s.t. 1 Intraosseous Infusion System | Pyng Medical Corp. | FMI | Class II | |
| K970334 | Nature's Cradle | Infant Advantage, Inc. | FMS | Class II | |
| K970317 | Modified E-Pack Procedure Kit | Ethicon, Inc | GAM | Class II | |
| K970303 | Saturne Multileaf Collimator | General Electric Co. | IXI | Class II | |
| K970180 | Vsa 3000 Vibratoryn Sensory Analyzer | Eare Consulting Service | LLN | Class I | |
| K964766 | Immage Immunochemistry System Alpha-1-Antitrypsin (Aat) | Beckman Instruments, Inc. | DEM | Class II | |
| K964762 | Immage Immunochemistry System Ceruloplasmin (Cer) Reagent | Beckman Instruments, Inc. | DDB | Class II |