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 |
|---|---|---|---|---|---|
| K980099 | Ultracision Laparosonic Coagulating Shears (Lcs-5(Lcsk5 and Lcsb5)) | Ethicon Endo-Surgery Inc | LFL | Unclassified | |
| K980091 | Lubriscan Ultra Scan Gel +, Model Rg2-60 | Cosmaceutical Marketing, Inc. | ITX | Class II | |
| K980081 | S-Rom Zirconia Ceramic Femoral Hip Head | Johnson & Johnson Professionals, Inc. | LZO | Class II | |
| K980079 | Coherent Tissue Morcellator Kit and Accessories | Lumenis Ltd | GCJ | Class II | |
| K974097 | Periacryl | Blacklock Medical Products, Inc. | EMA | Class II | |
| K974060 | Ministrip/ Serum and Urine Combo Hcg Test | International Newtech Development, Inc. | JHI | Class II | |
| K974059 | One Step Midstream Hcg Pregnancy Test | International Newtech Development, Inc. | LCX | Class II | |
| K970768 | Human Lyme Igm Western Blot Kit | Cambridge Diagnostics Ireland, Ltd. | LSR | Class II | |
| K970761 | Limited Human Lyme Igg Western Blot Kit (Cambridge Diagnostics Ireland) | Cambridge Diagnostics Ireland, Ltd. | LSR | Class II | |
| K965034 | Sorbastace | Hemostace, LLC | QSY | Unclassified | |
| K980889 | Uresil Nephro-Ureteral Stent | Uresil, LLC | LJE | Unclassified | |
| K980412 | Coloured Powdwr-Free Surgical Gloves | Kenwell International, Ltd. | KGO | Class I | |
| K980314 | Fetal D Tection Kit | Biopool Intl., Inc. | LIM | Class II | |
| K980237 | Gynex Endospeculum | Gynex Corp. | KNA | Class II | |
| K974302 | Light Diagnostics Simulfluor Flu A/flu B | Light Diagnostics | GNW | Class I | |
| K973697 | Airperm (Siflufocon a) Rigid Gas Permeable Ok Contact Lenses for Daily Wear Orthokeratology | Airperm, Inc. | MUW | Class II | |
| K964205 | Better-Tubing | Circulatory Technology, Inc. | DWF | Class II | |
| K963703 | Accuflo Monitoring System (1800)/ Accuflo Probe (8000) | International Biophysics Corp. | DPT | Class II | |
| K980627 | Neva System | Urometrics, Inc. | LIL | Unclassified | |
| K980554 | Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/enhancing) | Alden Optical Labs., Inc. | LPL | Class II | |
| K980505 | Hortmann Amdis-Oae Oae Analyzer | Hortmann AG | EWO | Class II | |
| K973064 | Keeler Tearscope-Plus | Keeler Instruments, Inc. | HJO | Class II | |
| K980871 | Lyphochek Whole Blood Control | Bio-Rad | DIF | Class I | |
| K980470 | Kht Soft Sooji Needle, Hand Acupuncture Needle | American Institute of Koryo Hand Therapy | MQX | Class II | |
| K980336 | IV Stands | Clinton Industries, Inc | FOX | Class I | |
| K980151 | Releasable Force Module | Ortho Kinetics Corp. | DZB | Class II | |
| K974745 | Manan Gwi Guide Wire Introducer | Medical Device Technologies, Inc. | DRC | Class II | |
| K974743 | Manan | Medical Device Technologies, Inc. | DRC | Class II | |
| K974742 | Manan Potts-Cournand Needle | Medical Device Technologies, Inc. | DRC | Class II | |
| K980941 | Safety Powderfree Blue Latex Examination Gloves (Polymer Coated) | Besglove Medicare Sdn. Bhd. | LYY | Class I | |
| K980940 | Safety Powderfree Blue Latex Examintion Gloves | Besglove Medicare Sdn. Bhd. | LYY | Class I | |
| K980939 | Safety Powdered Blue Latex Examination Gloves | Besglove Medicare Sdn. Bhd. | LYY | Class I | |
| K980819 | Biocircuits Ios Free Thyroxine (Ft4) Test Cartridges Biocircuits Ios Controls | Biocircuits Corp. | CEC | Class II | |
| K980803 | Sterile Powder-Free Latex Examination Gloves | Kenwell International, Ltd. | LYY | Class I | |
| K980716 | Advantage Chemiluminescence Prostate Specific Antigen (Psa) Immunoassay | Nichols Institute Diagnostics | LTJ | Class II | |
| K980682 | Fuji II | GC America Inc. | EMA | Class II | |
| K980679 | Endobon | Zimmer GmbH | LYC | Class II | |
| K980607 | Dermatherm 100 | New Star Lasers, Inc. | ILY | Class II | |
| K980478 | Playtex Tampons #03498 | Playtex, Inc. | HEB | Class II | |
| K980469 | Kht Sooji Needle, Hand Acupuncture Needle | American Institute of Koryo Hand Therapy | MQX | Class II | |
| K980448 | Model Ps-1 Pena Muscle Stimulator | Radionics, Inc. | IPF | Class II | |
| K980440 | Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw | Depuy, Inc. | HWC | Class II | |
| K980286 | Ultima Acetabular Roof Reinforcement Ring | Johnson & Johnson Professionals, Inc. | JDI | Class II | |
| K980243 | Parameter Developments Dicom Archival Server, (Das)/dicom Intranet Service (Dis) | Parameter Developments, Inc. | LMB | Class I | |
| K980187 | Mlt R694 Ruby Laser System | Medical Laser Technologies Ltd. | GEX | Class II | |
| K980142 | Featherlite Diode Laser | Laserlite, LLC | GEX | Class II | |
| K980138 | Spectrum Designs Symmetrical Chin Implant | Spectrum Designs, Inc. | FWP | Class II | |
| K980113 | Wallstent Enteral Endoprosthesis | Boston Scientific Corporation | MUM | Class II | |
| K980102 | Bti Humeral Intramedullary Rod System | Biodynamic Technologies, Inc. | HSB | Class II | |
| K980044 | Xenon 300Mx | Perkinelmer Optoelectronics | FSS | Class II |