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 |
|---|---|---|---|---|---|
| K882360 | Dermapik | Creative Scientific Equipment Corp. | SCL | Class II | |
| K882334 | Abbott Spectrum Simulstat Glucose/bun Reagent | Abbott Medical | CFR | Class II | |
| K882264 | Battle Creek Pillow | Battle Creek Equipment | IQK | Class I | |
| K882130 | Foley-Temp(tm) | Mallinckroot, Inc. | EYB | Class II | |
| K882096 | Scopix Video Imager | AGFA Healthcare Corp. | LMC | Class II | |
| K881685 | Fibrinogentest-O | Diatech, Inc. | GIS | Class II | |
| K881342 | Implantofix II Implantable Drug Delivery System | Burron Medical, Inc. | LJT | Class II | |
| K881132 | Laitinen's Trigeminus Stereoguide | Sandstrom Trade & Technology, Inc. | HAW | Class II | |
| K875127 | Novoste 4, 4.2, 5 and 6 French Catheters | Best Vascular, Inc. | DQO | Class II | |
| K883013 | Imx Ckmb | Abbott Medical | JHY | Class II | |
| K882963 | Spembly Medical 142 Cryo Unit | Spembly Medical, Ltd. | GEH | Class II | |
| K882962 | Series 40 & Series 42 Cryoprobes (R Series) | Spembly Medical, Ltd. | GEH | Class II | |
| K882890 | Wroblewski Spring Compression Wire System | Thackray USA | JDQ | Class II | |
| K882819 | Emit Hva Cannabinoid 100 Ng Assay | Syva Co. | LDJ | Class II | |
| K882812 | Omnifit Acetabular Shell Cement Spacer System | Osteonics Corp. | JDI | Class II | |
| K882727 | Amerlite Total Thyroid Control Sera Lan.4001 | Amersham Corp. | JJY | Class I | |
| K882719 | Easy-Test Emit Acetaminophen (Actm) No. 16653 | Em Diagnostic Systems, Inc. | LDP | Class II | |
| K882625 | Pharmacia Ige Ria Ultra | Pharmacia, Inc. | DGC | Class II | |
| K882611 | Emit Hva Barbiturate Assay | Syva Co. | DIS | Class II | |
| K882587 | A-Kem Albumin Reagent Kit for Astra System | A-Kem, Inc. | CIX | Class II | |
| K882586 | A-Kem Calcium Reagent Kit for Astra System | A-Kem, Inc. | CIC | Class II | |
| K882559 | Profile One Omni | Modular Diagnostic Systems, Inc. | JJE | Class I | |
| K882539 | Cleantech System | Schiff & Co. | JKA | Class II | |
| K882368 | Rep Hdl Electrophoresis Method | Helena Laboratories, Corp. | LBT | Class I | |
| K882340 | Lh Serozyme Immunoenzymetric Assay Kit,mag Sol Pha | Serono Diagnostics, Inc. | CEP | Class I | |
| K882256 | Magnesium Reagent Set | Tech-Neal Scientific, Inc. | JGJ | Class I | |
| K882228 | Revised Double Antibody Amphetamine | Siemens Healthcare Diagnostics Inc. | DJP | Class II | |
| K882155 | Cotube Hcg Irma Test | Bio-Rad | JHI | Class II | |
| K882119 | Telsteth Telemetric Stethoscope(tm) | Quantsonics, Inc. | DXH | Class II | |
| K881361 | Solid Phase Extraction Tubes | Supelco, Inc. | DJY | Class I | |
| K880489 | Clear Eye Garter Shield | Eye Garter Company, Inc. | HOY | Class I | |
| K874212 | Verimed Myo/prems | Verimed Holdings, Inc. | IPF | Class II | |
| K883217 | Schiff Reagent | Surgipath Medical Industries, Inc. | HZT | Class I | |
| K882768 | Laurier Sanitary Napkin | Kao Corp. | HHD | Class I | |
| K882049 | Meditron Mg-1000 Monopolar Generator | Xylog Corp. | GEI | Class II | |
| K881374 | Surgeons Gloves | Interpro Intl., Inc. | KGO | Class I | |
| K881299 | Ite Hearing Aid, Ear-Tronics Models: M1-M23 | Ear-Tronics, Inc. | ESD | Class I | |
| K875314 | Gl-35 Colposcopic Laser System | Laser Engineering, Inc. | HHR | Class II | |
| K862747 | 8800 Series Micro-Processor-Based Apnea Monitors | Atlas Researches, Ltd. | BZQ | Class II | |
| K883062 | Ats Schaudinn's Fixative W/acetic Acid | Alpha-Tec Systems, Inc. | LDW | Class I | |
| K883005 | Electronic Digital Thermometer | Hanson Scale Co. | FLL | Class II | |
| K883004 | Mono-Plus(tm) | Wampole Laboratories | KTN | Class II | |
| K882997 | (Dme/f-12 1:1), Catalog No. 200-2100 | J R Scientific | KIT | Class I | |
| K882996 | Dulbecco's Phosphate Buffered Saline No.210-3022 | J R Scientific | KIT | Class I | |
| K882995 | Fischer's Medium No. 200-2188 | J R Scientific | KIT | Class I | |
| K882994 | Dulbecco's Phosphate Buffered Saline No. 210-3021 | J R Scientific | KIT | Class I | |
| K882993 | Nutrient Mixture F-12 (Ham) No. 200-2071 | J R Scientific | KIT | Class I | |
| K882992 | Minimum Essential Medium, Alpha Modi. No.200-2091 | J R Scientific | KIT | Class I | |
| K882991 | Nutrient Mixture F-12 (Hat Variation) No. 200-2070 | J R Scientific | KIT | Class I | |
| K882990 | Rpmi-1640 Baker's Modification No. 200-2078 | J R Scientific | KIT | Class I |