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 |
|---|---|---|---|---|---|
| K972716 | Synermed Total Bilirubin Reagent Kit | Synermed, Inc. | CIG | Class II | |
| K972307 | Accurun 119 Anti-Hepatitis B E Antigen (Anti-Hbe) Positive Control | Boston Biomedica, Inc. | JJY | Class I | |
| K971922 | Innovasive 2.8Mm and 3.5Mm Roc Ez Suture Bone Fastener | Innovasive Devices, Inc. | MBI | Class II | |
| K971890 | Recovery Protrusio Cage | Zimmer GmbH | JDI | Class II | |
| K971807 | In the Ear, in the Canal, Completely in the Canal | Hear-Right, Inc. | ESD | Class I | |
| K971738 | Endopath Resposable Trocar System | Ethicon Endo-Surgery Inc | GCJ | Class II | |
| K971715 | Select Shoulder Offset Humeral Head Components | Sulzer Orthopedics, Inc. | KWS | Class II | |
| K971406 | Accurun 120 Hav Igg Positive Control | Boston Biomedica, Inc. | JJY | Class I | |
| K970962 | Jms Av Fistula Needle | Jms Co., Ltd. | FIE | Class II | |
| K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | KWP | Class II | |
| K964616 | Quatroloc Plasma Sprayed Femoral Component | Whiteside Biomechanics, Inc. | LPH | Class II | |
| K972721 | Roche Hemoglobin A1c Control N and Control P | Roche Diagnostic Systems, Inc. | JJX | Class I | |
| K972609 | Variant Express Glycohemoglobin Program | Bio-Rad | LCQ | Class II | |
| K972384 | Aq One Step Cocaine Test | Bionike Laboratories, Inc. | DIO | Class II | |
| K972278 | Cytoplast Regentex Titanium 250 | Osteogenics, Inc. | LYC | Class II | |
| K972245 | Tom Cat F.l., Tom Cat S.l. | A & A Medical, Inc. | MFD | Class II | |
| K971948 | Patient Restraint | E.M. Adams Co., Inc. | FMQ | Class I | |
| K971939 | Smith & Nephew Suture Collet | Smith & Nephew Endoscopy, Inc. | OCW | Class II | |
| K971929 | Amsino Urinary Leg Bag | Amsino Intl., Inc. | KNX | Class II | |
| K971853 | Endoview Spphire Lens Set | American Medical Devices, Inc. | HJK | Class II | |
| K971837 | Verres Needle, Cannula for M820, Cannula W/trumpet Valve for M 820 | CooperSurgical, Inc. | HET | Class II | |
| K971745 | Bard Composite Prosthesis | Davol Inc., Sub. C.R. Bard, Inc. | FTL | Class II | |
| K971705 | Implex Hep Acetabular Cup System, Cemented | Implex Corp. | JDI | Class II | |
| K971629 | Patient Latex Examination Glove (Prepowdered) | Besglove Medicare Sdn. Bhd. | LYY | Class I | |
| K970344 | Mdilog, Model Mdc-511 | Medtrak Technologies, Inc. | CAF | Class II | |
| K970014 | Trinity Sleeves, Huntleigh Pump Compatible(t.b.d.) | Delphi Consulting Group | JOW | Class II | |
| K964804 | Flexilog Ls | Oakfield Instruments, Ltd. | KLA | Class II | |
| K963521 | Imz Twin Plus - Cylinder | Imz, GmbH | DZE | Class II | |
| K963290 | Colorflo Option for the Oracle Invision Intravascular Ultrasonic Imaging System | Endosonics Corp. | IYO | Class II | |
| K962951 | Model Hs-2 TENS Device | Technalithics Laboratories, Inc. | GZJ | Class II | |
| K962777 | Amr Mini-Laparoscope | Applied Medical Resources Corp | HET | Class II | |
| K955477 | Hi-Tec CO2 Insufflator Type 1300 | Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz | HIF | Class II | |
| K972755 | V-12 Long Life 675 Hearing Aid | Vista Labs | ESD | Class I | |
| K972233 | Stryker Wedge Interference Screw System | Stryker Corp. | HWC | Class II | |
| K972042 | Pari Pep Therapy System | Pari Holding Co. | BWF | Class II | |
| K971747 | Amplaid 460 | Amplifon | EWO | Class II | |
| K971731 | Unigloves | Uni-Glove (USA), Inc. | LYY | Class I | |
| K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K971673 | 40 Cc Sumo | Boston Scientific Corporation | DSP | Class II | |
| K970812 | Pm 2002 Cc Proline | Planmeca Oy | EHD | Class II | |
| K970575 | Electro-Lite Elite Powered Wheelchair | Damaco | ITI | Class II | |
| K964226 | Memory Staple (20 Sizes Available) | Landos, Inc. | JDR | Class II | |
| K964017 | Affinity Blood Pump System | Avecor Cardiovascular, Inc. | DTQ | Class II | |
| K963451 | Anti-Tumor Expert System (Ates) for Radiation Therapy Treatment Planning | Topslane | IYE | Class II | |
| K962548 | Bsm Bone Substitute Material Kit | Etex Corp. | LYC | Class II | |
| K972608 | Randox Assayed Specific Protein Control | Randox Laboratories, Limited | JJY | Class I | |
| K972585 | Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen | Heinz Kurz GmbH Medizintechnik | ETA | Class II | |
| K972526 | Methadone Eia Assay | Diagnostic Reagents, Inc. | DJR | Class II | |
| K972492 | Bell Prosthesis (Partial) | Heinz Kurz | ETB | Class II | |
| K972459 | Rhinocell Nasal Packings | Boston Medical Products, Inc. | EMX | Class I |