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 |
|---|---|---|---|---|---|
| K981265 | Pagewriter 200I Interpretive Cardiograph Model M1770a with Acute Cardiac Ischemia Time Insensitive Predictive Instrumena | Hewlett-Packard Co. | LOS | ||
| K981252 | Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue Visibility Tinted, Lathe-Cut Fr) | Alden Optical Labs., Inc. | LPL | Class II | |
| K981103 | Turbosonics Limited Reuse Ultrasonic Tip | Alcon Laboratories | HQC | Class II | |
| K981063 | Automated Corneal Trephine | Laser Center Dev. Corp. | HRG | Class I | |
| K980814 | Puresperm | Nidacon International AB | MQL | Class II | |
| K981990 | Mrs-400, Maxi 400, Mrsl-400, Maxi 400L | D.B.I. America Corp. | EFB | Class I | |
| K981893 | Health + Aid Premium Pre-Powdered Latex Examination Gloves | M.R.G. Industries Sdn. Bhd. | LYY | Class I | |
| K981806 | Alkp | Abbott Medical | CJE | Class II | |
| K981724 | O.r.pro 300 Electrosurgical Generator Model 40001-100 | Medtrex, Inc. | GEI | Class II | |
| K981670 | Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw | Depuy, Inc. | HWC | Class II | |
| K981467 | Amm | Abbott Medical | JIF | Class I | |
| K981340 | Innovasive Devices Meniscal Dart Repair System | Innovasive Devices, Inc. | MAI | Class II | |
| K981333 | Nitrilon Correct-Touch | Biopro (M) Sdn Bhd | LZA | Class I | |
| K981309 | Osteo I-C Humeral Nail System | Osteonics Corp. | HSB | Class II | |
| K981304 | Nitrilon Correct-Touch | CT Intl. | LZA | Class I | |
| K981261 | Howmedica Scn Nail | Howmedica Corp. | HSB | Class II | |
| K981184 | Sharptrack Reusable Sharps Container | Bfi- Medical Waste Systems | FMI | Class II | |
| K981166 | Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 | Inrad | KNW | Class II | |
| K981151 | Opti-Free Supraclens Daily Protein Remover/alcon Wetting, Soaking, Conditioning and Disinfecting Solution Id 84392 | Alcon Laboratories | LPN | Class II | |
| K981150 | Solosite Gel Conformable Dressing | Smith & Nephew, Inc. | MGQ | Unclassified | |
| K981075 | Synthes (USA) (Synthes) Single Vector Distractor with Detachable Feet | Synthes (USA) Products LLC | MQN | Class II | |
| K974468 | Photonic Stimulator | Bales Scientific, Inc. | ILY | Class II | |
| K974321 | Hydrotone | North American Technical Services Corp. | ILJ | Class II | |
| K974251 | X-Cell Wound Dressing | Xylos Corporation | MGQ | Unclassified | |
| K973251 | Ksea Calcuson | Karl Storz Endoscopy-America, Inc. | FEO | Class II | |
| K981766 | Uric Acid | Abbott Medical | CDO | Class I | |
| K981621 | Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors | Suretex Prophylactics (India), Ltd. | LTZ | Class II | |
| K981470 | Worldwide Medical Technologies Needle Guide | Worldwide Medical Technologies, LLC | IZH | Class II | |
| K981330 | Quanta Lite Mpo Igg (Myeloperoxidase) Test Kit | Inova Diagnostics, Inc. | MOB | Class II | |
| K981328 | Quanta Lite Pr3 Igg (Serine Protease) Test Kit | Inova Diagnostics, Inc. | MOB | Class II | |
| K981286 | Superflow Irrigation and Aspiration Tubing Sets | Armm, Inc. | KDH | Class II | |
| K980873 | Konica Direct Digitizer Regius Model 330 | Konica Corp. | LMA | Class II | |
| K980728 | Fukuda Denshi Dynascope Model Ds-5000 Series Telemetry System | Fukuda Denshi USA, Inc. | DSI | Class II | |
| K973013 | Opti-Plast (Centurion) 5.5F Angioplasty Catheter | Vas-Cath, Inc. | LIT | Class II | |
| K981657 | Philips Thoravision | Philips North America LLC | KPR | Class II | |
| K981548 | Nfc Needlefree Connector Model 69900 | Filtertek, Inc. | FPA | Class II | |
| K981547 | Nfc Needlefree Y-Site, Model 69970 | Filtertek, Inc. | FPA | Class II | |
| K981217 | Platinum Reading, Review & Analysis Workstation | GE Healthcare | LLZ | Class II | |
| K981167 | Stealth Pilot Kit/ Stealth Spacer/face Mask Kit | Dhd Healthcare Corp. | CAF | Class II | |
| K981094 | Medrad Neurovascular Coil | Medrad, Inc. | MOS | Class II | |
| K981053 | Kodak Digital Sciences (Kds) Image View | Eastman Kodak Company | LMD | Class I | |
| K980002 | Koala Vascular Clamps and Inserts | Boss Instruments, Ltd. | DXC | Class II | |
| K974843 | Duracon(r) Small Stabilizer Tibial Insert | Howmedica Corp. | JWH | Class II | |
| K981196 | Meditec Link | Aesculap-Meditec North America | HQF | Class II | |
| K981080 | Scoop 1 | Transtracheal Systems | BTO | Class II | |
| K981013 | Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum Tube | Becton Dickinson Vacutainer Systems | JKA | Class II | |
| K980234 | The Network System | Medical Sni, Ltd. | LLZ | Class II | |
| K974885 | Blackstone Medical Inc. Anterior Cervical Plate System | Blackstone Medical, Inc. | KWQ | Class II | |
| K974473 | Easy Rider Micro Catheter | Medtronic, Inc. | KRA | Class II | |
| K974176 | Babylog 8000 Plus | Drager, Inc. | CBK | Class II |