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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K820411 | Liquizyme Chloride Reagent | American Research Products Co. | JFS | Class II | |
| K820394 | Technicon Ra-1000 System Add. Analyt | Technicon Instruments Corp. | CKA | Class I | |
| K820391 | Abuscreen Radioimmunoassay for Cannabi | Hoffmann-La Roche, Inc. | LAT | Class II | |
| K820388 | Liquizyme Co2reagent Set | American Research Products Co. | JFL | Class II | |
| K820378 | Ld-L Tris System Pack Test | Boehringer Mannheim Corp. | CFJ | Class II | |
| K820363 | Disposable Surgical Garments | Alphamedix, Inc. | FYA | Class II | |
| K820359 | Hot Mini 15 & Hot Mini 24 | Hot Mini International, Inc. | IMD | Class I | |
| K820344 | Rowe Shoulder Instr. for Bankhart Repair | New England Surgical Instrument Corp. | HTD | Class I | |
| K820327 | Model 450Xl CO2 Surgical Laser | Lumenis Ltd | GEX | Class II | |
| K813604 | Omni Stim II | Omni Intl., Inc. | IPF | Class II | |
| K813443 | Bx-400 Sport | Bloomex International, Inc. | IPF | Class II | |
| K813410 | Bx-400 Jesse Jimbody | Bloomex International, Inc. | IPF | Class II | |
| K827126 | Technomed Generator, Radiographic, 3 Phase | Tecnomed, Inc. | |||
| K827124 | Ralco Collimator, Automatic, Radiographic | Tecnomed, Inc. | |||
| K827123 | Spectra (Ultraviolet Products) | Ultralite | |||
| K820307 | Tecnomed Generator, Radiograph., 3 Phase | Tecnomed, Inc. | IZO | Class I | |
| K820306 | Ralco Collimator, Automatic Radiographic | Tecnomed, Inc. | KPW | Class II | |
| K820291 | Knee Support for X-Ray & Surgery | The Anspach Effort, Inc. | FWZ | Class I | |
| K820290 | Self Retaining Retractor for Hand Surg | The Anspach Effort, Inc. | GAD | Class I | |
| K820288 | Mini Shields Menstrual Pads | I.C.D. Industries, Inc. | HHD | Class I | |
| K820287 | Maxi Shields Menstrual Pads | I.C.D. Industries, Inc. | HHD | Class I | |
| K820280 | Spectra 305/350 | Ultralite | KGL | Class II | |
| K820261 | Monitor CO2 Laser System | Cooper Medical, SRL | HHR | Class II | |
| K820259 | Sterile Cytology Brushes | American Endoscopy, Inc. | GEE | Class I | |
| K820198 | Derma-Aid | Winfield Laboratories, Inc. | NAB | Class I | |
| K820195 | Or Specialties Vaginal Pack | Howard Medical Co. | EFQ | Unclassified | |
| K820124 | Integral Sector Module | Siemens Gammasonics, Inc. | IYO | Class II | |
| K813533 | Electric Muscle Stimulator | Myo-Tronics Research, Inc. | IPF | Class II | |
| K813199 | Skin Temperature Sensing Vinyl Strip | T. G. & E. Medical | KPD | Class II | |
| K813183 | No-Boil Vitabin B12 5760 Folate 125I | Corning Medical & Scientific | CDD | Class II | |
| K813177 | US Aloka Ssd-256 Ultrasonic Scanner | U. S. A. Imaging Corp. | IYO | Class II | |
| K813172 | Condom-Multipal Styles | Circle Rubber Corp. | HIS | Class II | |
| K812686 | Sinuscope | JEDMED Instrument Company | IYO | Class II | |
| K827125 | Ralco Collimators, Manual, Radiographic | Tecnomed, Inc. | |||
| K827087 | P1808 Mobile C-Arm Image Intensifier | Precise Optics | |||
| K820417 | #506 Port. Vital Functions Neonatal Mon | GE Medical Systems Information Technologies, Inc. | DRT | Class II | |
| K820416 | #505 Port. Vital Functions Neonatal Mon | GE Medical Systems Information Technologies, Inc. | DRT | Class II | |
| K820414 | Universal Testing & Analysis Systems | LKC Technologies, Inc. | GWF | Class II | |
| K820392 | Ortho* Bi-Level Assayed Alcohol Diluen | Ortho Diagnostic Systems, Inc. | LAS | Class I | |
| K820360 | Aalto Ldh Isoenzyme Control Serum | Aalto Scientific Ltd. | JJT | Class I | |
| K820355 | Disposable Diaphragm Domes | Medex, Inc. | DRS | Class II | |
| K820352 | Analgesia Breathing Circuit | Cryogentics Northwest, Inc. | CAI | Class I | |
| K820347 | Accu-Staph | Carr-Scarborough Microbiologicals, Inc. | LHT | Class I | |
| K820346 | Cali-Pipette | Carr-Scarborough Microbiologicals, Inc. | LIB | Class I | |
| K820345 | Cali-Loop | Carr-Scarborough Microbiologicals, Inc. | LIB | Class I | |
| K820342 | Physiological Pressure Transducer #900 | Bentley Laboratories, Inc. | DRS | Class II | |
| K820341 | Cortisol-Squibb Radioimmunoassay Kit | E. R. Squibb & Sons, Inc. | CGR | Class II | |
| K820340 | T3 Uptake-Squibb Diagnostic Kit | E. R. Squibb & Sons, Inc. | KHQ | Class II | |
| K820329 | Estradiol Kit by Ria | Immuchem Corp. | CHP | Class I | |
| K820308 | Ana-Disc System | Flow Laboratories, Inc. | KZJ | Class I |