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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K891912 | Amresco Urea Nitrogen (Bun) Reagents, Prod # 7123 | American Research Products Co. | CDQ | Class II | |
| K891702 | Patient Examination Gloves (Latex) | Thai Nam Rubber Gloves Co., Ltd. | LYY | Class I | |
| K891644 | Sambord Latex Patient Examination Gloves | Polymint Industrial Co., Ltd. | LYY | Class I | |
| K891374 | Patient Examination Gloves (Latex) | M.R.G. Industries Sdn. Bhd. | LYY | Class I | |
| K893737 | Directigen 1-2-3 Infectious Mononucleosis Test | Ortho-Clinical Diagnostics, Inc. | KTN | Class II | |
| K893199 | Phaco-Injector(tm) Intraocular Lens Implant Instr | Advanced Medical Optics, Inc. | HNR | Class I | |
| K893125 | Beckman Epsilon(tm) Ige Reagent Kit | Beckman Instruments, Inc. | DGO | Class II | |
| K893117 | Glucometer Qa Blood Glucose Mtr/glucofilm Test St | Bayer Corp. | CGA | Class II | |
| K892838 | Iron System Pack Reagents | Boehringer Mannheim Corp. | JIY | Class I | |
| K892454 | Kulzer Inlay System | Kulzer GmbH | EBF | Class II | |
| K892452 | Palaseal(r) | Kulzer GmbH | EBI | Class II | |
| K892419 | Npg 2 Base Metal Alloy | Aalba Dent, Inc. | EJF | Class I | |
| K892388 | The Tongue Cleaner | Rajiv R. Shah | LCN | Class I | |
| K892259 | Jesberg Esophagoscope | Zinnanti Surgical Instruments, Inc. | EOX | Class II | |
| K892224 | D-Chem(tm) T-Uptake Test Kit for T-Uptake Determin | Photec Diagnostics, Inc. | KHQ | Class II | |
| K892121 | Spiro-Link Real Time Spirometry System | Biocom Intl., Inc. | BZC | Class II | |
| K892001 | Dex-Cell Hysteroscopy Fluid Delivery Device | Dexide, Inc. | HIG | Class II | |
| K891922 | Amresco Cholesterol Reagents, Prod. # 7325 | American Research Products Co. | CHH | Class I | |
| K891694 | The Smile Machine | Brilliant Industries, Inc. | JEQ | Class I | |
| K891672 | Pul-Tron 100K Professional Spirometer | Advanced Medical Systems, Inc. | BZG | Class II | |
| K891604 | The Cen-Slide(tm) Centrifuge Tube | Davstar California, Inc. | KEW | Class I | |
| K891270 | Microtrak Eia Autoreader | Syva Co. | JJQ | Class I | |
| K891235 | Primus Model Clc 330 | Trinity Biotech (Primus Corporation dba Trinity Biotech) | LCP | Class II | |
| K891096 | Vis-Disk Hcg (Eia) Jpl-041M | Leeco Diagnostics, Inc. | DHA | Class II | |
| K891095 | Vis-Disk Hcg (Eia) Lyophilized Jpl-044M | Leeco Diagnostics, Inc. | DHA | Class II | |
| K890728 | Sterile Irrigation Trays | Cypress Medical Products LLC | KYZ | Class I | |
| K890476 | Adel - Model 986 Infant Warmer | Adel Medical, Ltd. | FMZ | Class II | |
| K890433 | Implant Paralleling Device (I.p.d.) | J.E. Josephson, D.M.D. | EFB | Class I | |
| K890323 | Max-1 (Exercise Electrocardiograph) | Marquette Electronics, Inc. | DSI | Class II | |
| K890271 | Alpha Model I Ite Hearing Aid | Alpha Instruments, Inc. | ESD | Class I | |
| K884884 | Ossicular Prosthesis: 8 Partial, 3 Total | Porex Technologies Corp. of Georgia | ETA | Class II | |
| K881196 | Am 706 Electromyograph, Stim., Neuro., External | Biometer Intl. A/S | IPF | Class II | |
| K893709 | Coherent Marie Argon Photocoagulator | Coherent Medical Group | HQF | Class II | |
| K893707 | Auto Suture Surgiport Depth Guide and Skirt | United States Surgical, A Division of Tyco Healthc | DRC | Class II | |
| K892877 | Cradle, Hospital Bed Clothing | Warsaw Orthopedic, Inc. | FNJ | Class I | |
| K892866 | Automatic Cranial Drill (Perforator) | Acra Cut, Inc. | HBF | Class II | |
| K892857 | Harvesting Tube | Conmedcorp | CAC | Class II | |
| K892808 | Kinetic Model 700 | Kinetic Biomedical Services, Inc. | FSY | Class II | |
| K892516 | Candela Pldl-1 Pulsed Dye Laser | Candela Corporation | GEX | Class II | |
| K892058 | Isl Qc 2000 | Intelligent Surgical Lasers, Inc. | LXS | Class II | |
| K892052 | Sarns Medical Cart | 3M Company | LDQ | ||
| K891990 | Rubeola Igg Clin-Elisa Test System, Cat. #4600 | Clinical Sciences, Inc. | LJB | Class I | |
| K891769 | Magniscan 5000 Mr System | General Electric Co. | LNH | Class II | |
| K891690 | Kodak Ektascan Image Manager | Eastman Kodak Company | LMB | Class I | |
| K891282 | Mic-100 with Cryoprobes | Frigitronics of Connecticut, Inc. | GEH | Class II | |
| K891180 | Transesophageal Ultrasound Accessories Kit | Ingress Technologies, Inc. | DXP | Class II | |
| K890874 | Biochem 520 Breath Indicator | Biochem International, Inc. | CCK | Class II | |
| K890845 | Premise Series Bed | Batesville American Mfg. Co. | FNL | Class II | |
| K890499 | Bivona Ventilator Isolator System | Bivona Medical Technologies | CAI | Class I | |
| K890443 | Caspar Scalp Clip, Applier | Aesculap Instruments Corp. | HBO | Class II |