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 |
|---|---|---|---|---|---|
| K903874 | Fibrinotest(tm) - Fibrinogen Assay | Haemachem, Inc. | GIS | Class II | |
| K903690 | Medtronic (R) Model 3625 Screener | Medtronic, Inc. | GZB | Class II | |
| K910249 | Stratus Estradiol Fluoremetric Enzyme | Baxter Healthcare Corporation | CHP | Class I | |
| K910141 | Children Sunglasses | Consolidated Stores Intl. Corp. | HQY | Class I | |
| K910061 | K-Module II Heat Therapy System | Baxter Healthcare Corporation | ILO | Class II | |
| K910044 | Milenia Cocaine Metabolite | Siemens Healthcare Diagnostics Inc. | KLN | Class II | |
| K910006 | Avd Intimax (Tm) Biliary Catheter | Applied Vascular | FGE | Class II | |
| K905855 | Vpw2877e7 X Ray Power Supply | Varian Canada, Inc. | IZO | Class I | |
| K905742 | Clearblue Easy | Unipath, Ltd. | LCX | Class II | |
| K905707 | Baxter Laparoscopic Cholangiography Catheters | Baxter Healthcare Corporation | FGE | Class II | |
| K905650 | Kinetic Alkaline Phosphatase Determination | Biochemical Trade, Inc. | CJE | Class II | |
| K905619 | Creatinine (Rate) Reagent Set | Biochemical Trade, Inc. | CGX | Class II | |
| K905477 | Olympus Urine Ph Calibrators Levels I and II | Em Diagnostic Systems, Inc. | JIS | Class II | |
| K905164 | Tube Declogger | Nova Design Technologies, Ltd. | KNT | Class II | |
| K905155 | High Speed Cereamic Bearing Turbine Handpieces | Star Dental Mfg. Co. | EFB | Class I | |
| K905076 | Whiteside Ortholoc Modular Tibial Constrain.insert | Dow Corning Wright | JWH | Class II | |
| K904317 | Avalon General Purpose Scanner, Preview Gp | Avalon Technology Corp. | DPW | Class II | |
| K903065 | Primary Manufacturer Sunglasses | Mao Lin Ent. | HQY | Class I | |
| K902986 | G.e. Dxd 325/350/350Ii/dxd 525/525Ii Generators | Electromek Diagnostic Systems, Inc. | IZO | Class I | |
| K902728 | 7.5 Mhz Bi Plane Rectal Probe (P/n: 041-815) | Ausonics Pty, Ltd. | ITX | Class II | |
| K910442 | Patient Examination Gloves | Asian Latex, Ltd. | LYY | Class I | |
| K910226 | Dural Dissectors | Acra Cut, Inc. | HAO | Class I | |
| K910225 | Bone Pad Remover | Acra Cut, Inc. | HAO | Class I | |
| K905793 | Cobe Centry 2 Bicart Option Kit | Cobe Laboratories, Inc. | FKP | Class II | |
| K905421 | Exit Alarm | Alertcare | KMI | Class I | |
| K905305 | Safe-Site Needle Cover | North American Medical Products, Inc. | FMI | Class II | |
| K905252 | Aloka 680 Diagnostic Ultrasound Scanning System | GE Medical Systems Information Technologies, Inc. | ITX | Class II | |
| K905061 | Apollo Mobile Scale | Apollo Enterprise, Ltd. Co. | FRW | Class I | |
| K905007 | Standard Breast Boards; Deluxe Breast Board | Bionix Development Corp. | IYE | Class II | |
| K904839 | Patient Exam Gloves(mfg: Yung Chieh Enterprise) | Up to Date, Inc. | LYY | Class I | |
| K904045 | #504 Mini Compressor | Medical Industries America, Inc. | BTI | Class II | |
| K903497 | Flexcomp Dsp & Procomp | Thought Technology Ltd. | HCC | Class II | |
| K902184 | Maxi Aspirator | Medical Industries America, Inc. | BTI | Class II | |
| K910199 | Medtronic Model 3487A Pisces-Quad Lead | Medtronic, Inc. | GZB | Class II | |
| K910192 | Auto Suture Endoscopic Ta Surgical Stapler | United States Surgical, A Division of Tyco Healthc | GDW | Class II | |
| K905768 | Pleur-Evac Chest Drainage Systems | Deknatel, Inc. | KDQ | Class II | |
| K905673 | Ab-Trol II Coagulation Control Plasm Cat. No. 5183 | Helena Laboratories, Corp. | GGN | Class II | |
| K905499 | Scimd 7 Fr. Triguide Guiding Catheter | Scimed Life Systems, Inc. | DQO | Class II | |
| K905484 | Accu-Tec System for Tissue Expander Injection Port | Mentor | LCJ | Unclassified | |
| K905466 | Sterile Disposable Surgical Drape/abdominal Drape | Angiosystems, Inc. | KKX | Class II | |
| K905465 | Sterile Dispos Surgical Drape/c-Section Drape | Angiosystems, Inc. | KKX | Class II | |
| K905426 | Auto Suture Modified Endo Stream Suc./irri. Device | United States Surgical, A Division of Tyco Healthc | HET | Class II | |
| K905422 | PVC Round Wound Drains | Axiom Medical, Inc. | GBX | Class I | |
| K905396 | Hemastix Reagent Strips | Kulzer GmbH | JIO | Class II | |
| K905388 | Cobe Centrysystem 3 Bicart Option Kit | Cobe Laboratories, Inc. | FKP | Class II | |
| K905378 | Playtex Non-Deodorant and Deodorant Tampons | Playtex Family Products, Inc. | HIL | Class II | |
| K905369 | Ust-2266U-5 Cw Doppler Transducer | GE Medical Systems Information Technologies, Inc. | JOP | Class II | |
| K905366 | Magnetom Sp/as (Actively Shielded) | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K905287 | Ifsa Sterile Silk Braided Nonabsor Surg Sutures | Internacional Farmaceutica, S.A. de C.V. | GAP | Class II | |
| K905286 | Ifsa Sterile Nlylon Monofil Nonabsor Surg Sutures | Internacional Farmaceutica, S.A. de C.V. | GAR | Class II |