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 |
|---|---|---|---|---|---|
| K981854 | Olympus Serum Protein Multicalibrator, | Olympus Diagnostica GmbH | JIT | Class II | |
| K981846 | Parenchymal Bolt Pressure Monitoring Kit | Camino Neurocare, Inc. | GWM | Class II | |
| K981788 | Scimed 6 French Wiseguide Guide Catheter | Scimed Life Systems, Inc. | DQO | Class II | |
| K980916 | Powder-Free Latex Examination Gloves with Protein Labeling Claim | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | |
| K980588 | Clarus Endoscopic Discectomy System Sitetrac Model 6000 | Clarus Medical Systems, Inc. | GAD | Class I | |
| K980109 | Cyclotech Cyclosporine Oral Solutions Dispenser | Sangstat Medical Corp. | KYX | Class I | |
| K981792 | Solution Administration Set | Baxter Healthcare Corporation | FPA | Class II | |
| K980083 | 3I Orthodontic Abutment, Orthobutment | ZimVie US Corp LLC | DZE | Class II | |
| K971434 | A.m.t. G-Tube Balloon Replacement Gastrostomy Feeding Device | Applied Medical Technologies | KNT | Class II | |
| K982342 | Dinamap Mps Select Portable Monitor | Critikon Company, LLC | MSX | Class II | |
| K982239 | Circuit Guard | Arc Medical, Inc. | CAH | Class II | |
| K982057 | Bc 900 Slit Lamp | Haag-Streit AG | HJO | Class II | |
| K981966 | Nosebleed Noseclip | Michael M. Knott, M.D. | EMX | Class I | |
| K981809 | Caroline Guide | Surgical Solutions, LLC | HAW | Class II | |
| K981761 | Sysmex Kx-21, Automated Hematology Analyzer | Sysmex Corporation | GKL | Class II | |
| K981155 | Flapmaker Disposable Microkeratome | Hawken Industries | HNO | Class I | |
| K980876 | Asthma Monitor Am2 | Erich Jaeger GmbH & Co. KG | BZG | Class II | |
| K974535 | Discam Digital Imaging System | Marcher Enterprises, Ltd. | HKI | Class II | |
| K964437 | Gb-1002 TENS with Massage | Skylark Device Co., Ltd. | GZJ | Class II | |
| K982622 | El-Ana Profiles: El-Ena/5 | Theratest Laboratories, Inc. | LLL | Class II | |
| K982292 | Prealbumin Calibrator | Siemens Healthcare Diagnostics Inc. | JIT | Class II | |
| K982229 | Bi-Dent | Valley Forge Scientific Corp. | EKZ | Class II | |
| K982150 | El-Ana Profiles: El-Ena/4 | Theratest Laboratories, Inc. | LLL | Class II | |
| K981751 | Sinuscope and Accessories | Henke Sass Wolf of America, Inc. | EOB | Class II | |
| K981541 | Clearstar Enteral Nutrition Pump | Frantz Medical Development, Ltd. | LZH | Class II | |
| K981364 | Pyrilinks-D Assay Kit | Metra Biosystems, Inc. | JMM | Class I | |
| K981257 | Jelfine-52 (Code Name Rd-0901) | J.F. Jelenko & Co., Inc. | EJS | Class II | |
| K981244 | Bw-1 (Code Name Rd-0807) | J.F. Jelenko & Co., Inc. | EJT | Class II | |
| K980888 | Glycacor | Exocell, Inc. | LCP | Class II | |
| K980174 | Durex Colors and Scents | London Intl., LLC | HIS | Class II | |
| K982697 | Modification to Ensemble Central Station Monitor | Mennen Medical, Inc. | DSI | Class II | |
| K982649 | Vitros Chemistry Products Tdm Performance Verifiers I, II, and III | Ortho-Clinical Diagnostics, Inc. | DIF | Class I | |
| K982637 | Immulite Psa Control Module, Model Lpscm | Siemens Healthcare Diagnostics Inc. | JJY | Class I | |
| K982619 | Hp Anesthesia Gas Monitor (Watertrap), Model A02 | Hewlett-Packard Co. | CCL | Class II | |
| K982473 | Tumor Marker Control | Siemens Healthcare Diagnostics Inc. | JJY | Class I | |
| K982260 | Markwell Gauze Sponge | Markwell Intl., Inc. | LWH | Class I | |
| K982219 | Microalbustix Reagent Strips | Bayer Corp. | JIR | Class I | |
| K982065 | Sterile Silicone External Wound Cover | Specialty Surgical Products, Inc. | MIB | Class II | |
| K981839 | Acs:centaur Psa2 Immunoassay | Chiron Diagnostics Corp. | LTJ | Class II | |
| K981782 | Low Profile Port Attachable Catheter with Blue Flex Tip / 8Fr. Inroducer Kit Implantable Vascular Access System | Arrow Intl., Inc. | DYB | Class II | |
| K981703 | Ksea Unimat 45 | Karl Storz Endoscopy-America, Inc. | BTA | Class II | |
| K981478 | Acs:centaur Cea | Chiron Diagnostics Corp. | DHX | Class II | |
| K981284 | Better-Bladder (Bb) | Circulatory Technology, Inc. | DTN | Class II | |
| K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.p.A. | JOW | Class II | |
| K980287 | Siemens Sc9000/sc9015 Tcp02/c02 Module | Siemens Medical Solutions USA, Inc. | KLK | Class II | |
| K973426 | Ans 2000 ECG Monitor and Respiration Pacer | D. E. Hokanson, Inc. | DPS | Class II | |
| K982586 | Powder Free Surgeons Glove | Shiva Medicare, Ltd. | KGO | Class I | |
| K982579 | Latex Examination Gloves Powder Free | Shiva Medicare, Ltd. | LYY | Class I | |
| K982465 | Deroyal Industries, Inc. Defogger | DeRoyal Industries, Inc. | OCT | Class II | |
| K982464 | Scc-23 Safety Clamp and Cutter | Women First Healthcare, Inc. | KNA | Class II |