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 |
|---|---|---|---|---|---|
| K952742 | Blood Urea Nitrogen Reagent System | Medical Diagnostic Technologies, Inc. | CDQ | Class II | |
| K952695 | Boston Medical Latex Exam Gloves | Shun Thai Rubber Gloves Industry Co., Ltd. | LYY | Class I | |
| K952676 | Branemark System Ball Attachment System | Nobelpharma USA, Inc. | DZE | Class II | |
| K952596 | Theophylline Enzyme Immunoassay | Diagnostic Reagents, Inc. | KLS | Class II | |
| K952591 | Royal Shield Non-Sterile Blue Colored Bubble Gum Scented Latex Examination Gloves | Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. | LYY | Class I | |
| K952589 | Royal Shield Pink & Blue Colored Non-Sterile Latex Examination Gloves | Shield Gloves Manufacturer (M) Sdn Bhd | LYY | Class I | |
| K952268 | Model Delta, Om Oxygen Concentrator | Caire, Inc. | CAW | Class II | |
| K952226 | C-Flex Septal Splints | Trebay Medical Corp. | LYA | Class I | |
| K952223 | Xenon Gas Breathing Circuit | Intertech Resources, Inc. | IYT | Class II | |
| K952221 | Bsc/ca 30 & 40 Sensation, Models 930 & 940 | Boston Scientific Corporation | DSP | Class II | |
| K952173 | Hewlett-Packard Model M1264b Cathstation | Hewlett-Packard Co. | DPS | Class II | |
| K952112 | Amigo Grand Tour | Amigo Mobility Intl., Inc. | INI | Class II | |
| K952089 | Rich-Mar Cm-II Combined Muscle Stimulator, Interferential, TENS & Therapeutic Ultrasound Device | Rich-Mar Corp. | LIH | Class II | |
| K951956 | Osteonics Series 7000 Total Knee Full Tibial Bone Augementation Blocks & Wedges | Osteonics Corp. | JWH | Class II | |
| K951949 | Clear Hub Spinal Needle, 18, 20, 22, 25 Ga. | Baxter Healthcare Corporation | BSP | Class II | |
| K951835 | Modified Human Tubal Fluid (Mhtf) With/without Penicillin G Dolium, With/without Streptomycin Sulfate | Life Technologies Corporation | MFD | Class II | |
| K951771 | Community Balance Performance Monitor or Community Bpm | Sms Technologies, Ltd. | KHX | Class I | |
| K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | HSB | Class II | |
| K951584 | Alkaline Phosphatase (Alp/amp) Procedure No. 247 | Sigma Diagnostics, Inc. | CJE | Class II | |
| K951414 | Champion Physioacousticc Recliner-Transporter Chair | Champion Mfg, Inc. | IRO | Class I | |
| K951331 | Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor | Boehringer Mannheim Corp. | KHP | Class I | |
| K951227 | Dx1 | Creative Biomedics, Inc. | BZG | Class II | |
| K951157 | Dx1-Portable | Creative Biomedics, Inc. | BZC | Class II | |
| K951116 | Acromed Pedicle Screw | Acromed Corp. | MNH | Class II | |
| K950925 | Jedmed Laryngeal Scope | JEDMED Instrument Company | EOQ | Class II | |
| K950920 | Dupont Dimension Total Protein Method | Dupont Medical Products | CEK | Class II | |
| K950120 | Smart Plug | Hgm, Inc. | GEX | Class II | |
| K950098 | Needle Safety Cover | Hammer-Plane, Inc. | CBT | Class I | |
| K950074 | Wright-Loc(tm) Spinal Fixation System | Wrightmedicaltechnologyinc | MNH | Class II | |
| K945660 | Autoject 2 | Owen Mumford USA, Inc. | KZH | Class II | |
| K945047 | Bcw 600 Power Wheelchair | Wheelchairs of Kansas | ITI | Class II | |
| K944721 | 9000 Infusion Pump | Graseby Medical, Ltd. | FRN | Class II | |
| K942863 | Epidural Needle | Spinal Specialties, Inc. | BSP | Class II | |
| K952968 | Dilatation Catheter, Balloon | Boston Scientific Corporation | LJE | Unclassified | |
| K952748 | Auto Suture* Chemosite Implantable Drug Delivery System** | United States Surgical, A Division of Tyco Healthc | LJT | Class II | |
| K952353 | Ez-Comp | Adm, Inc. | EBF | Class II | |
| K952333 | Plasma Arc Curing System | American Dental Technologies, Inc. | EBF | Class II | |
| K943100 | Stryker Operating Laparoscope | Stryker Corp. | HET | Class II | |
| K940092 | Usci Input Introducer Set | Usci, Div. C.R. Bard, Inc. | DYB | Class II | |
| K914749 | Wavicide(r) -01 | Wave Energy Systems, Inc. | MED | Class II | |
| K953510 | Hip Joint Femoral (Hemi-Hip) Metal/polymer Cemented or Uncemented Prosthesis | Encore Orthopedics, Inc. | KWY | Class II | |
| K953488 | Unscented Menstrual Liner | Paragon Trade Brands, Inc. | HHD | Class I | |
| K953487 | Unscented Menstrual Shield | Paragon Trade Brands, Inc. | HHD | Class I | |
| K953387 | Ectra Ligament Release System | Smith & Nephew Dyonics, Inc. | HRX | Class II | |
| K953164 | Alalysis Package for Dental Applications for Xpeed, Xpress, Xvision | Toshiba America Medical Systems, In.C | LLZ | Class II | |
| K952443 | Karl Storz Endoscopy Powder Blower | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K952416 | Tracheostomy Care Kit | Medi-Flex Hospital Products, Inc. | BTO | Class II | |
| K952393 | Okamoto Condom | Okamoto U.S.A., Inc. | HIS | Class II | |
| K952215 | Serim Hisense Test Kit | Serim Research Corp. | FIP | Class II | |
| K952213 | Alcon Series 20000 Legacy Phacoemulsifier | Alcon Laboratories | HQC | Class II |