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 |
|---|---|---|---|---|---|
| K954274 | Mepore (6X7) | Scott Health Care | KMF | Class I | |
| K953599 | Clamp Assembly | J.B.S., S.A. | KWP | Class II | |
| K953558 | Kis II Lg Hex Screw & Cylinder Implants | Implant Center of the Palm Beaches | DZE | Class II | |
| K953396 | Cardiovit at-1C, at-2C | Schiller America, Inc. | LOS | ||
| K953162 | Olympus High Flow Insufflation Unit | OLYMPUS Corporation of the Americas | HIF | Class II | |
| K952922 | Biogran Bioactive Glass Synthetic Bone Graft Material | DSM Biomedical, Inc. | LYC | Class II | |
| K952293 | Vascutek Gelweave Vascular Graft | Vascutek, Ltd. | DSY | Class II | |
| K945930 | Ria Latex Condom with Spermicide, Ria Color Condom with Spermicide | Line One Laboratories & Trading Co. | HIS | Class II | |
| K945756 | Imagn(tm) 2000 System | Buckman Co., Inc. | GKZ | Class II | |
| K940047 | Spermicidally Lubricated Condom | Ansell, Inc. | HIS | Class II | |
| K936294 | Sentry(tm) Anterior/posterior Spinal Systems | Sofamor Danek Mfg., Inc. | KWP | Class II | |
| K955471 | Incl Endoscope | Sofamor Danek USA,Inc. | HRX | Class II | |
| K955467 | Neuroview Coaxial Bipolar Electrode | Neuro Navigational Corp. | GEI | Class II | |
| K955109 | Vl2600 Handswitching Pencil with Holster | Medtronic, Inc. | GEI | Class II | |
| K954965 | Zomed Model 20 & 30 Electrosurgical Probes | Zomed Intl. | GEI | Class II | |
| K954933 | Ektachem Clinical Chemistry Slide for Acetaminophen | Johnson & Johnson Clinical Diagnostics, Inc. | LDP | Class II | |
| K954931 | Neo-Med Dls-1100 | Neo-Laboratories, LLC | GEX | Class II | |
| K954627 | Ectra II Ligament Release System | Smith & Nephew Dyonics, Inc. | HRX | Class II | |
| K954566 | Specific Allergen Modules for the Alastat Microplate Allergen-Specific Ige System | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K954460 | Ilt Surgical Laser | Ion Laser Technology | GEX | Class II | |
| K954447 | C-Reactive Protein Latex Kit | Randox Laboratories, Limited | DCK | Class II | |
| K954439 | Oratec Interventions Model Tac 1000 Monopolar Cautery Probe | Oratec Interventions, Inc. | GEI | Class II | |
| K954409 | Ps Medical Ipi Vascular Access Catheter | Pudenz-Schulte Medical Research Corp. | LJS | Class II | |
| K954145 | Wako Autokit Ch50 | FUJIFILM Healthcare Americas Corporation | DAE | Class II | |
| K953632 | Serim Pyloritek Test Kit | Serim Research Corp. | LYR | Class I | |
| K952287 | Reaads Anti-Phosphatidylserine Quantitative Test Kit | Reaads Medical Products, Inc. | MID | Class II | |
| K952073 | Paci-Temp, Pacifier with Digital Thermometer | Intelligent Product Limited Co. | FLL | Class II | |
| K951600 | Mill-Rose Rotatable Polypectomy Snare | Mill-Rose Laboratory | FDI | Class II | |
| K950970 | Infusion Set | Surgiplast, Ltd. | FPA | Class II | |
| K955091 | Disposable Powder Free Vinyl Synthetic Gloves | Safehealth Medical Supply Corp. | LYZ | Class I | |
| K955049 | Olympus Fg-45/46-1 Grasping Forceps | OLYMPUS Corporation of the Americas | FFL | Class II | |
| K955030 | Square One Safety Syringe | Square One Medical, LP | MEG | Class II | |
| K954870 | Sims Deltec Anti-Siphon Valve | Sims Deltec, Inc. | FPA | Class II | |
| K954723 | Enzyme Immunoassay Ana Screening Test Kit | Helix Diagnostics, Inc. | LKJ | Class II | |
| K954700 | Enzyme Immunoassay Lupus Screen Test Kit | Helix Diagnostics, Inc. | LKJ | Class II | |
| K954591 | Aia-Pack Cort Assay | Tosoh Medics, Inc. | JFT | Class II | |
| K954422 | Per-Q-Cath Mid-Line | Gesco Intl., Inc. | LJS | Class II | |
| K954387 | T Class Hyperbaric Facilities | Reimers Systems, Inc. | CBF | Class II | |
| K954349 | Fiberflo Hollow Fiber Cartridge Water Filters | Medivators Inc | FIP | Class II | |
| K954316 | Aurora Surgical Diode Laser System W/accessories | Premier Laser Systems, Inc. | GEX | Class II | |
| K954092 | Alternate Sterlization Process & Modified Df-1 Lead Connector (Modification) | Medtronic, Inc. | DXY | Class III | |
| K953866 | Minix 834M & Minix St 8331M Pulse Generators (Modification) | Medtronic, Inc. | DXY | Class III | |
| K953465 | Kentemp | Kentron Health Care, Inc. | FLK | Class II | |
| K952490 | Imagetiter Instrument, Ana Test Kit & Calibrator Serum | Roche Image Analysis Systems | LJM | Class II | |
| K952154 | Scinitrex Power Free Blue Nitrile Examination Gloves | Wembley Rubber Products (M) Sdn Bhd | LZA | Class I | |
| K952051 | Scinitrex (Powder Free Nitrile Examination Gloves) | Wembley Rubber Products (M) Sdn Bhd | LZA | Class I | |
| K951938 | Scinitrex (Powder Free Green Nitrile Examination Gloves | Wembley Rubber Products (M) Sdn Bhd | LZA | Class I | |
| K951768 | Teves Ecm Plus Thermocouple | Advanced Medical Concepts, Inc. | BTR | Class II | |
| K950201 | Argyle(r) Hydrophilic Coated Thoracic Catheter | Sherwood Medical Co. | JOL | Class II | |
| K950042 | Swan Neck Presternal Peritoneal Dialysis Catheter | Accurate Surgical Instruments Co. | FJS | Class II |