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 |
|---|---|---|---|---|---|
| K963414 | Multiple Belts | J. T. Posey Co. | FMQ | Class I | |
| K963410 | Posey Straight Jackets | J. T. Posey Co. | FMQ | Class I | |
| K963363 | Hologic Qdr Series X-Ray Boe Densitometers | Hologic, Inc. | KGI | Class II | |
| K963356 | Phased Array Shoulder Coil | Philips North America LLC | MOS | Class II | |
| K963260 | Dressing Change Trays | Busse Hospital Disposables | FMF | Class II | |
| K963211 | Uniseal Gloves (Low Protein,powder Free) | American Healthcare Products Inc | LYY | Class I | |
| K955749 | Tex-Care Sterile Stockinette | Flynt Amtex, Inc. | KKX | Class II | |
| K964062 | N Protein Strandard Sl | Behring Diagnostics, Inc. | JIX | Class II | |
| K963773 | 24457-010 Secure All Pelvic Holder/24458-010 Secure All Body Belt | Tecnol Medical Products, Inc. | FMQ | Class I | |
| K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,vascutek Gelsoft Patch,vascutek Thin Wall Carotid Patch | Vascutek, Ltd. | DXZ | Class II | |
| K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | GXD | Class II | |
| K963563 | Ultracare Vest Style Body Holder with Safety Sleeves, Small(24454-010,020,030,040,015,025,035,045,115,125,135,145) | Tecnol Medical Products, Inc. | FMQ | Class I | |
| K963561 | Ultra Care Vest Style Body Holder, Small (24455-010,020,030,040,24456-010,020,030,040) | Tecnol Medical Products, Inc. | FMQ | Class I | |
| K963557 | System 2 Zippered Body Holder, Small/medium 24453-010,24453-020,24453-030 | Tecnol Medical Products, Inc. | FMQ | Class I | |
| K963556 | Secure-All 1-Piece Body Holder, Small/medium (24451-010,020,24452-010,020,030) | Tecnol Medical Products, Inc. | FMQ | Class I | |
| K963554 | 24448-010 Secure-All Finger Control Mitt | Tecnol Medical Products, Inc. | FMQ | Class I | |
| K963462 | Comfor Foam Limb Holders- Single Strap | Bird & Cronin, LLC | FMQ | Class I | |
| K963344 | Disposable Ss-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope | Cogentix Medical, Inc. | FAM | Class II | |
| K963323 | Endo Vip | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K962389 | Euromedical Reinforced Endotracheal Tube | Unomedical Sdn Bhd | BTR | Class II | |
| K962128 | Tebco (Thoracic Electrical Bioimpedance Cardiac Output) | Hemo Sapiens, Inc. | DXG | Class II | |
| K961407 | Speed-Cut | Gallini Intl., Inc. | KNW | Class II | |
| K960512 | Gemini Pc-Itx | Imed Corp. | FRN | Class II | |
| K954923 | Bactec Fungal Medium | Becton Dickinson Diagnostic Instrument Systems | JTA | Class I | |
| K951226 | Vitalmax 4000/Minipack 3100/3000 | Pace Tech, Inc. | DSK | Class II | |
| K964466 | Palladia 75 (Pm-11) | Gateway Alloys, Inc. | EJT | Class II | |
| K964064 | Rdi Lipidirect Magnetic Ldl Reagent | Reference Diagnostics, Inc. | MRR | Class I | |
| K964063 | Rdi Ldl Precipitation Reagent | Reference Diagnostics, Inc. | MRR | Class I | |
| K963840 | Cedia Phenytoin II Assay | Boehringer Mannheim Corp. | DIP | Class II | |
| K963809 | Cool-Zone | Kappler USA | FYA | Class II | |
| K963742 | Latex Examination Gloves, Powdered | Arista Medi Prima | LYY | Class I | |
| K963488 | Specialty Progressive(methafilcon A)multifocal Soft(hydrophilic)contact Lens for Daily Wear(clear and Tinted) | Specialty Ultravision, Inc. | LPL | Class II | |
| K963327 | Tidal Wave Carbon Dioxide Monitor, Model 610 | Novametrix Medical Systems, Inc. | CCK | Class II | |
| K963010 | Lifestyle Gp (Telefocon B) Rigid Gas Permeable Multifocal Contact Lens for Daily Wear | Permeable Technologies, Inc. | HQD | Class II | |
| K961917 | Medtronic Mustang Steerable Guide Wire (M-45Fr, M45fx) | Medtronics Interventional Vascular | DQX | Class II | |
| K961606 | Metro Focal Aspheric (Polymacon) | Metro Optics of Austin, Inc. | LPL | Class II | |
| K960315 | Flavored Latex Patient Examination | P.T. Irama Dinamika Latex | LYY | Class I | |
| K964286 | Zomed Passive Temperature Probe | Zomed Intl. | FLL | Class II | |
| K963968 | Flyway | Look Style, S.r.l. | HQY | Class I | |
| K963955 | Dr. Bert's Suncare Products Peeper Keepers | Bert & Joe'S, Inc. | HQY | Class I | |
| K963891 | Rx 96E | Jeneric/Pentron, Inc. | EJH | Class II | |
| K963890 | Various Sunglasses (Non-Prescription) | Italian Eyewear, Inc. | HQY | Class I | |
| K963786 | Tempfil F | Sybron Dental Specialties, Inc. | EBG | Class II | |
| K963484 | Bard High Flow Papillotome | Bard Interventional Products Div. | KNS | Class II | |
| K963439 | Pediatric Limb Holders | J. T. Posey Co. | FMQ | Class I | |
| K963437 | Pelvic Holders | J. T. Posey Co. | FMQ | Class I | |
| K963411 | Posey Laptop Trays | J. T. Posey Co. | FMQ | Class I | |
| K963151 | Medi-Trace 5700 Resting ECG Electrode | Graphic Controls Corp. | DRX | Class II | |
| K962863 | Karl Storz Model 264305-20 Electronic Endoflator | Karl Storz Endoscopy-America, Inc. | HIF | Class II | |
| K962771 | Burke Congenital Thoracoscopy Instruments | Pilling Weck, Inc. | DWS | Class I |