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 |
|---|---|---|---|---|---|
| K962551 | Cardioserv S | Marquette Electronics, Inc. | LDD | Class II | |
| K962483 | Midas Rex III Motor | Midas Rex Pneumatic Tools, Inc. | HBB | Class II | |
| K962096 | Medline, Hypoallergenic, Pre-Powdered Non-Sterile and Sterile Latex Examination Gloves | MEDLINE INDUSTRIES, LP - Northfield | LYY | Class I | |
| K961999 | Schneider Guider Softip Guiding Catheters | Boston Scientific Corporation | DYG | Class II | |
| K961906 | Uni-Gard Quik Cath(sizes 8 French Through 18)Ug 10008,10010,10012,10014,10016,10018 | Spectrum Medsystems Corp. | EYZ | Class I | |
| K961460 | Lweet Cone Biopsy Instrument | CooperSurgical, Inc. | HGI | Class II | |
| K960770 | Matchmaker/propaque Porcelain | Davis Schottlander & Davis, Ltd. | ELL | Class II | |
| K960630 | Anspahc Speed Reducer | The Anspach Effort, Inc. | HBB | Class II | |
| K955835 | Fluid Barrier Boot Knee & Ankle-High | Instrument Makar, Inc. | FXP | Class I | |
| K954311 | Koh Colpotomizer System | CooperSurgical, Inc. | HEW | Class II | |
| K953742 | Bifurcated Y-Extension | Medtronic, Inc. | GZB | Class II | |
| K964108 | Fact Plus Pregnancy Test | Direct Access Diagnostics | LCX | Class II | |
| K963258 | Peacock System | Nomos Corp. | IYE | Class II | |
| K963245 | Immulite Latex-Specific Ige | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K963133 | Ps-Unit Cassette/serum Hcg | International Newtech Development, Inc. | JHI | Class II | |
| K963132 | Mini Strip/serum Hcg | International Newtech Development, Inc. | JHI | Class II | |
| K963106 | Chromolize Pai-1 Kit | Medical Diagnostic Technologies, Inc. | GGP | Class II | |
| K963016 | Simon Nitinol Filter System | Nitinol Medical Technologies, Inc. | DTK | Class II | |
| K963014 | Simon Nitinol Filter/straight Line System | Nitinol Medical Technologies, Inc. | DTK | Class II | |
| K962062 | Orgentec Anti-Sm Elisa | American Laboratory Products Company | LJM | Class II | |
| K962057 | Orgentec Anti-Rnp/sm Elisa | American Laboratory Products Company | LJM | Class II | |
| K961588 | Total Iron (Nitro-Paps) Reagent Set | Horiba Instruments Incorporated | JIY | Class I | |
| K961566 | Biocircuits Ios Tsh Test Cartridges/thyroid Controls | Biocircuits Corp. | JLW | Class II | |
| K955733 | Hyloc Interference Screw (Cannulated)/(non-Cannulated) | Depuy, Inc. | HWC | Class II | |
| K963927 | Team Caries Indicator | Centrix, Inc. | LFC | Class II | |
| K963737 | Hycem Aplicap | Espe GmbH & Co. KG. | EMA | Class II | |
| K963453 | Cfi Restraint Belt (Cfi-168) / Cfi Restraint Belt (Cfi-4046) | Domico Med-Device, LLC | FMQ | Class I | |
| K963420 | Cancellous Screw Washer | Orthopaedic Biosystems, Ltd. | HTN | Class II | |
| K963236 | M & R Disposable Electrode (14200) | M & R Mfg., Inc. | GXY | Class II | |
| K963226 | Surgical Fabrics | Boston Scientific Corporation | FTL | Class II | |
| K963038 | Medi-Trace 3600 Series of ECG Monitoring Electrode | Graphic Controls Corp. | DRX | Class II | |
| K962825 | Shield Von Willebrand Factor Activity (Elisa) Assay | Shield Diagnostics, Ltd. | GGP | Class II | |
| K962055 | Orgentec Anti-Scl 70 Elisa | American Laboratory Products Company | LJM | Class II | |
| K962054 | Orgentec Anti-Ss-A(ro) Elisa | American Laboratory Products Company | LJM | Class II | |
| K962053 | Orgentec Anti-Jo-1 Elisa | American Laboratory Products Company | LJM | Class II | |
| K962052 | Orgentec Abti-Ss-Bb(la) Elisa | American Laboratory Products Company | LJM | Class II | |
| K961665 | O Butment Et Implant | O Co., Inc. | DZE | Class II | |
| K961509 | Intra-Aortic Balloon Pump System 97 Modified | Datascope Corp. | DSP | Class II | |
| K961334 | Heartport Handswitch Electrocautery Probe | Heartport, Inc. | GEI | Class II | |
| K961333 | Heartport Multifire Clip Applier | Heartport, Inc. | DSS | Class II | |
| K955775 | Safeconnect Valve (Catalog No. Xxxx) | Faulding Medical Device Co. | FPA | Class II | |
| K964073 | Bme Bone Drill Bits | Biomedical Ent., Inc. | GEY | Class I | |
| K963639 | Acromed Pedicle Screw | Acromed Corp. | KWP | Class II | |
| K963609 | Phase Plus | Zhermack S.p.A. | ELW | Class II | |
| K963524 | Ksea Large Joint Arthroscopy Set | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K963491 | Stuckey Strap-3 Finger Restraints | Stuckey Ent., Inc. | FMQ | Class I | |
| K963478 | Sleeved/sleeveless Vest Restraint | DeRoyal Industries, Inc. | FMQ | Class I | |
| K963473 | Reusable Limb Holder | DeRoyal Industries, Inc. | FMQ | Class I | |
| K963472 | Pediatric Vest Restraint | DeRoyal Industries, Inc. | FMQ | Class I | |
| K963471 | Super Security Restraint | DeRoyal Industries, Inc. | FMQ | Class I |