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 |
|---|---|---|---|---|---|
| K902853 | Gravity Plus Controller/compounder | Fergy Corp. | LHI | Class II | |
| K911898 | Raichem(tm) Spia(tm) Haptoglobin Reagent | Reagents Applications, Inc. | DAD | Class II | |
| K911895 | Qualtex Suture Booties | DeRoyal Industries, Inc. | MDM | Class I | |
| K911775 | Omnicath Implanted Catheter and Depot | Omnitron Intl., Inc. | KXK | Class II | |
| K911392 | Antimicrobial Susceptibility Test Panel (Cefotetan | Alamar | JWY | Class II | |
| K911391 | Antimicrobial Suscept. Test Panel (Ceftizoxime) | Alamar | JWY | Class II | |
| K911390 | Antimicrobial Suscept. Test Panel(trimethoprim) | Alamar | JWY | Class II | |
| K911389 | Antimicrobial Susceptibility Test Panel (Imipenem) | Alamar | JWY | Class II | |
| K911204 | Qualtex Skin Staple Extractor | DeRoyal Industries, Inc. | GDT | Class I | |
| K911141 | Hemocue(r) B-Glucose Microcuvette/photometer | HemoCue AB | CGA | Class II | |
| K911060 | Immunomatrix Theophyline Assay System | Immunomatrix | KLS | Class II | |
| K910903 | Inflate-a-Cuff #7014 | Pa Medical Corp. | DXQ | Class II | |
| K910896 | Disposable Anesthesia Breathing Circuit | Specialty Packaging Producs, Inc. | CAI | Class I | |
| K910882 | Propaq 102El, 104El and 106El | Protocol Systems, Inc. | DRT | Class II | |
| K910754 | Model 43100A Series Defibrillator, Modification | Hewlett-Packard Co. | LDD | Class II | |
| K910682 | Robicsek Probe/retractor | Bio-Vascular, Inc. | DWP | Class II | |
| K910678 | Tro-Gard | Conmedcorp | KGX | Class I | |
| K910553 | Roche Apolipoprotein Standard | Roche Diagnostic Systems, Inc. | DER | Class II | |
| K905658 | Systemate Creatinine (Epos Application) #65413 | Em Diagnostic Systems, Inc. | CGX | Class II | |
| K905571 | Electro-Nerve Stimulator TENS Model,inf 4150/A | BioMedical Life Systems Inc. | LIH | Class II | |
| K911851 | Immunowell Sm Antibody Test | General Biometrics, Inc. | LKP | Class II | |
| K911850 | Immunwell Sjogren`s Syndrome B (La) Antibody Test | General Biometrics, Inc. | LKO | Class II | |
| K911849 | Immunowell Sjogrens Syndrome a (Ro)antibody Test | General Biometrics, Inc. | LKO | Class II | |
| K911848 | Immunowell Rnp/sm Antibody Test | General Biometrics, Inc. | LKP | Class II | |
| K911579 | Starkey Trilogy Program Hear Aid Cc/ce Models | Starkey Laboratories, Inc. | ESD | Class I | |
| K911266 | Modified Pk Tp Control | Olympus Corp. | GMT | Class II | |
| K911140 | Bard(r) Endocardial Balloon Array | C.R. Bard Inc | DRF | Class II | |
| K910861 | Percutaneous Introd W/sideport/three-Way Stopcock | Daig Corp. | DYB | Class II | |
| K910834 | Qbc Autoreader | BD Becton Dickinson Vacutainer Systems Preanalytic | GKZ | Class II | |
| K910813 | Met-Etch | Gresco Products, Inc. | EBC | Class II | |
| K910731 | Disposable Retractable Needle Syringe | Safe Tech Medical Products, Inc. | FMF | Class II | |
| K910679 | Genesis I Automated Cell Counter | Alicia Diagnostics, Inc. | GKL | Class II | |
| K910645 | Disposable Patient Cable | Diag Corp. | DSA | Class II | |
| K910620 | Cardiocap Dr-124 Recorder | Datex Division Instrumentarium Corp. | DRG | Class II | |
| K910595 | Model 5311B a-V Pacing System Analyzer | Medtronic, Inc. | DTC | Class II | |
| K910552 | Roche Reagent for Apolipoprotein B | Roche Diagnostic Systems, Inc. | MSJ | Class I | |
| K910551 | Roche Reagent for Apolipoprotein a-1 | Roche Diagnostic Systems, Inc. | MSJ | Class I | |
| K910450 | Card Guard-3000 ECG Telephone Adapter | Medtech Industries, Inc. | DXH | Class II | |
| K905468 | Pylori-G Fiax Test Kit | Whittaker Bioproducts, Inc. | LYR | Class I | |
| K905300 | Permanent Pacing Lead | Oscor Medical Corp. | DTB | Class III | |
| K905182 | Oscor Medical Corp. Permanent Pacing Pad | Oscor Medical Corp. | DTB | Class III | |
| K905114 | A.p.graph Iii(tm) Cardiovascular Analyzer | Research Consultants, Inc. | JOM | Class II | |
| K905087 | Trios 02 | BIOTRONIK AG | DXY | Class III | |
| K905049 | Quidel Helicobacter Pylori Postive/negative Contr | Ortho-Clinical Diagnostics, Inc. | LYR | Class I | |
| K904738 | Pylori Stat Test Kit | Whittaker Bioproducts, Inc. | LYR | Class I | |
| K911566 | Clearblue Easy | Unipath, Ltd. | LCX | Class II | |
| K911332 | Spectacle Frame | Australian Optical Co., Inc. | HQZ | Class I | |
| K911132 | Multiple, Surgical Drape Pack | Central Georgia Ancillary Health Systems | FZI | Class II | |
| K910951 | Opthlamic Frames | United Optical, SpA | HQZ | Class I | |
| K910721 | Biotrol Protein Multilevel Standards | Biotrol, USA, Inc. | JIS | Class II |