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 |
|---|---|---|---|---|---|
| K890884 | Abuscreen Fp for Barbiturates | Roche Diagnostic Systems, Inc. | DIS | Class II | |
| K890705 | Medimod(tm), Model 8900 | Medical Devices Inc. | GZJ | Class II | |
| K890704 | Bte Hearing Aid Oticon Model: E42p | Oticon, Inc. | ESD | Class I | |
| K890577 | Kenlor Liquid Urine Control | Kenlor Industries, Inc. | JJW | Class I | |
| K890576 | Kenlor Human Spinal Fluid Control Liquid | Kenlor Industries, Inc. | JJY | Class I | |
| K890569 | Neyoro 65Cf | Deringer-Ney, Inc. | EJT | Class II | |
| K890568 | Ultima Lite | Deringer-Ney, Inc. | EJT | Class II | |
| K890558 | Wellshire Baselink | American Executive Technology | DXH | Class II | |
| K890529 | Alastigard | Unitek Corp. | EJF | Class I | |
| K890421 | Imx B2-Microglobulin | Abbott Medical | JZG | Class II | |
| K890337 | Triglycerides - Gpo Reagent | Alpkem Corp. | CDT | Class I | |
| K890278 | Total Protein Reagent | Sigma Chemical Co. | CEK | Class II | |
| K890131 | Target(tm) Quantitative Hcg | V-Tech, Inc. | JHI | Class II | |
| K890081 | Calius-Isabel Canovas Sunglasses | Roseburg SA | HQY | Class I | |
| K885274 | Rocket Endocervical Brush | A & A Medical, Inc. | HHT | Class II | |
| K885183 | Endoscopic Light Source | Technology for Imaging, Inc. | HRX | Class II | |
| K885135 | Micro-Fine High Freq. Mobile Mammo. System Mf-150 | Bennett X-Ray Corp. | IZH | Class II | |
| K884984 | M40 K Karaya Gum Disp. Microtape ECG Electrode, 40 | S & W Medico Teknik | DRX | Class II | |
| K884983 | M55 K Karaya Gum Disp. Microtape ECG Electrode, 55 | S & W Medico Teknik | DRX | Class II | |
| K884917 | Resuscitator's Guard Suction Control System | Amg Medical Equipments, Inc. | IZH | Class II | |
| K884897 | Four-Channel/eight-Channel Thermal Array Recorder | Mennen Medical, Inc. | DSF | Class I | |
| K884867 | Optifield I and II Automated Perimeters | Optimed, Inc. | HPT | Class I | |
| K884504 | Electrode Gel | Herbert Stanley Co. | DPS | Class II | |
| K884455 | Model 702 Ecg/respiration/temperature | Ivy Biomedical Systems, Inc. | DRT | Class II | |
| K883903 | Nr2000 Cardiac Monitor | Nirad, Ltd. | DPS | Class II | |
| K883732 | Argis Pulmonary Function Testing System | Advanced Signal Processing, Inc. | BZC | Class II | |
| K881970 | Model Mr2000 Heated Respiratory Humidifier | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K890748 | Allevyn Tracheostomy Dressing | Smith & Nephew United, Inc. | NAD | Class I | |
| K890669 | Statspin Hdl-Cholesterol Precipitating Micro Tube | Norfolk Scientific, Inc. | LBR | Class I | |
| K890645 | Estradiol Maiaclone Radioimmunoassay Kit | Serono-Baker Diagnostics, Inc. | CHP | Class I | |
| K890534 | Modified Uriqual(tm) Urinalysis Control Level 1 | Fisher Scientific Company L.L.C. | JJW | Class I | |
| K890457 | Modified Minimed Mdl404-Sp/504-S Drug Insulin Pump | Medtronic, Inc. | FRN | Class II | |
| K890442 | Shape-Actio Urinalysis Controls | Actio, Inc. | JJY | Class I | |
| K890395 | Biotrol Iron Reagent | Biotrol, USA, Inc. | JIY | Class I | |
| K890327 | Biopsy Needle Guide Attachment | Elscint, Inc. | FCG | Class II | |
| K890317 | Total Protein Reagent | Medical Analysis Systems, Inc. | CEK | Class II | |
| K890269 | Alkaline Phosphatase Isoenzyme Reagents | Beckman Instruments, Inc. | CIN | Class II | |
| K890203 | Adms Biopsy Needle | Advanced Diagnostic Medical Systems, Inc. | FCG | Class II | |
| K885334 | Vac-Rite | BD Becton Dickinson Vacutainer Systems Preanalytic | GCX | Class II | |
| K885307 | Flipscreen (Tm) Total E Immunoassay | Alerchek, Inc. | DGC | Class II | |
| K885187 | Model 1000 Electronic Clinical Thermometer | Mon-A-Therm, Inc. | FLL | Class II | |
| K884809 | Delfia Shbg Kit | Pharmacia, Inc. | CDZ | Class I | |
| K884724 | Aspartate Aminotransferase (Ast) | Catachem, Inc. | CIT | Class II | |
| K884528 | Seralyzer Digoxin Assay/test Mod/calib/contr/ames | Kulzer GmbH | KXT | Class II | |
| K884489 | c&t Pregnancy Test Kit | Healthcheck Corp. | LCX | Class II | |
| K884133 | Preemicare Series 4000 Phototherapy Lamp | Preemicare Corp. | LBI | Class II | |
| K883814 | Delfia Hlh Spec Kit | Pharmacia, Inc. | CEP | Class I | |
| K890675 | The Turbox Analyser System Complement C3 and C4 | Unipath, Ltd. | CZW | Class II | |
| K890070 | Total Bilirubin Reagent, Concentrated | Trace Scientific, Ltd. | CIG | Class II | |
| K885277 | Spinal Anesthesia Tray | Preferred Medical Products, LLC | CAZ | Class II |