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 |
|---|---|---|---|---|---|
| K910088 | Scitech Bi-Manual Adapter Clips | Scitech Industries Partnership | HQQ | Class II | |
| K910051 | Sharplan Nd:yag Surg Laser, 3065, Sharplaser 65 | Sharplan Lasers, Inc. | GEX | Class II | |
| K910020 | Capintec Thyroid Uptake System-Various Models | Capintec Instruments, Inc. | IZO | Class I | |
| K905848 | Life Pt Vasc Access Pt W/detach Cath(lps 6013)Modi | Strato Medical Corp. | LJT | Class II | |
| K905846 | Strato Low Profile Port(lps 1055)/Modification | Strato Medical Corp. | LJT | Class II | |
| K905624 | Probe Surgeon's Gloves- Sterile | Glove India Pvt., Ltd. | KGO | Class I | |
| K904848 | Port-of-Orgin(tm) Single-Use Trocar and Sleeve | Origin Medsystems, Inc. | HET | Class II | |
| K904421 | Cms Oncoprobe (Tm) | Cryomedical Sciences, Inc. | GEH | Class II | |
| K904420 | Disposable Fiber Optic Delivery System | Fiber Delivery Concepts, Inc. | GEX | Class II | |
| K901540 | Model Rfg-3C Radiofrequency Lesion Generator | Radionics, Inc. | GXD | Class II | |
| K911300 | Microsurgical Instruments | Danek Medical, Inc. | HRX | Class II | |
| K911175 | Sri Ferritin Immoenzymetric Assay(mag Solid-Phase) | Serono-Baker Diagnostics, Inc. | DBF | Class II | |
| K911057 | Dermatek 4000 | Anacom General Corporation | INX | Class II | |
| K910922 | Osteonics Cdh Hip Stem | Osteonics Corp. | JDI | Class II | |
| K910590 | Abuscreen Ontrak for Benzodiazepine | Roche Diagnostic Systems, Inc. | JXM | Class II | |
| K910539 | Rheumajet RF | Biokit USA, Inc. | DHR | Class II | |
| K910525 | Microline Screen for Methamphetamine | Drug Screening Systems, Inc. | DIT | Class II | |
| K910315 | Picc Insertion Kit/p.i.c. & Picc Exchang Kit/p.e.k | Sorex Medical | LJS | Class II | |
| K910292 | Mast Cla Allergy System | Mast Immunosystems | DHB | Class II | |
| K905851 | Strato Plast W/pre-Attach Cath(lps 6015)/Modified | Strato Medical Corp. | LJT | Class II | |
| K905847 | Strato Life Port II Dual Lumen Port/modification | Strato Medical Corp. | LJT | Class II | |
| K905459 | Surgical Procedure Tray/laparoscopy Cholecystectom | Angiosystems, Inc. | LRO | Class II | |
| K904254 | Na Alpha 1 Microglobulin Kit | Behring Diagnostics, Inc. | JZG | Class II | |
| K903002 | Probet (Tm) | Gynopharma, Inc. | HFF | Class II | |
| K910036 | Surg Tech,inc. 30 Gauge Straight Extrusion Needles | Surgical Technologies, Inc. | GAA | Class I | |
| K911267 | Radiographic/fluoroscopic Table Model 9004 | Tri W-G, Inc. | IXR | Class II | |
| K911121 | Ciba Corning Acs Ckmb Immunoassay | Ciba Corning Diagnostics Corp. | JHX | Class II | |
| K911056 | Du Pont Dimension(r) Phenytoin (Ptn) Method | E.I. Dupont de Nemours & Co., Inc. | DIP | Class II | |
| K910893 | Target(tm) Cannabinoids-R Test | V-Tech, Inc. | LDJ | Class II | |
| K910892 | Target(tm) Cannabinoids-V Test | V-Tech, Inc. | LDJ | Class II | |
| K910829 | Lyphochek Benzo/tca Control Serum, Levels 1 and 2 | Bio-Rad | LAS | Class I | |
| K910697 | Il Theophylline Assay System | Instrumentation Laboratory Co. | KLS | Class II | |
| K910666 | Vitek Anaerobe Identification Card, Modification | Vitek Systems, Inc. | JSP | Class I | |
| K910658 | Abuscreen Ontrak for Methamphetamine | Roche Diagnostic Systems, Inc. | DKZ | Class II | |
| K910589 | Abuscreen Fp for Cannabinoids (50-100) | Roche Diagnostic Systems, Inc. | LDJ | Class II | |
| K910578 | Mclaughlin Laparoscopic Grasper | Marlo Surgical Technology | HIS | Class II | |
| K910573 | Glucose V | Caro Med, Inc. | CGA | Class II | |
| K910424 | Teethmate-F | Kuraray Co. | EMA | Class II | |
| K910411 | Microzyme Tsh Enzyme Immunoassay Kit | IMMUNOTECH s.r.o. | JLW | Class II | |
| K910355 | Il Phenobarbital Assay System | Instrumentation Laboratory Co. | DLZ | Class II | |
| K910305 | Gem-Premier System | Mallinckrodt Sensor Systems, Inc. | JGS | Class II | |
| K910278 | Abuscreen(r) Ontrak(tm) for Amphetamine(500 Ng/ml) | Roche Diagnostic Systems, Inc. | DKZ | Class II | |
| K910255 | Flow Cytometry Fitc/pe Compensation Kit | Sigma Diagnostics, Inc. | JIW | Class II | |
| K910227 | Mx4043---Series, Intrauterine Pressure Catheter | Medex, Inc. | KXO | Class II | |
| K910211 | Orth-Evac(tm) Suction Hand Bulb Model No. 01-150 | Deknatel, Inc. | CAC | Class II | |
| K910185 | Synchron Cx4, Cx5, and Cx7 Clinical Analyzer | Beckman Instruments, Inc. | JJE | Class I | |
| K910097 | Electone Ite Model Premier | Electone, Inc. | ESD | Class I | |
| K905844 | Strato Stand Metal Ports (Lps 1013/1015)/Modified | Strato Medical Corp. | LJT | Class II | |
| K905740 | Resorbable Bone Plug | Zimmer GmbH | ESD | Class I | |
| K904935 | Respironics' Digital Manometer | Respironics, Inc. | CAP | Class II |