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 |
|---|---|---|---|---|---|
| K980557 | Sonoline Elegra Diagnostic Ultrasound System with Superficial Musculoskeletal Imaging | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K980402 | Capintec Model 292 Electrometer | Mirion Technologies (Capintec), Inc. | IYE | Class II | |
| K980391 | Seraquest Anti-Dsdna | Quest Intl., Inc. | LRM | Class II | |
| K980357 | Konan Noncon Robo Pachy Specular Microscope and Opticl Pachymeter | Konan, Inc. | HKI | Class II | |
| K980322 | Accent 16, Accent 22 | GE Healthcare | OXO | Class II | |
| K980299 | Apex Oximeter | Marquette Medical Systems, Inc. | DQA | Class II | |
| K980294 | Acs Hi-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic Coating | Boston Scientific Corporation | DQX | Class II | |
| K980282 | Uresil Dilator with Radiopaque Marker | Uresil, LLC | DRE | Class II | |
| K980279 | Sony Dxc-Ls1 Color Video Camera | Sony Medical Electronics Co. | GCJ | Class II | |
| K980276 | Stelkast Proven Cemented, Semi-Constrained Total Knee System | Globus Medical, Inc. | JWH | Class II | |
| K974840 | Abuscreen Online II for Opiates 300/2000, Abuscreen Online Opiates Calibration Pack, Abuscreen Online Opiates Control | Roche Diagnostic Systems, Inc. | DJG | Class II | |
| K973986 | Mectest | Meco Industries | DIO | Class II | |
| K973874 | Acl Clip-in Plate | Innovasive Devices, Inc. | MBI | Class II | |
| K973556 | Imex Medical Systems, Inc. Imexlab 9000 | Imex Medical Systems, Inc. | IYN | Class II | |
| K972793 | Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable | Radi Medical Systems AB | DQX | Class II | |
| K981278 | Elecsys Calcheck Ca 125Ii | Roche Diagnostics GmbH | JJX | Class I | |
| K981225 | Aspartate Aminotransferase (Ast) | Abbott Medical | CIT | Class II | |
| K981221 | Aspartate Aminotransferase Activated ( Ast Activated) | Abbott Medical | CIT | Class II | |
| K981164 | Powder Free Chlorinated Gloves-(Textured) | Pan-Century Rubber Products Sdn. Bhd. | LYY | Class I | |
| K980759 | Diamedix Is-Ena-6 Screen Test System | Diamedix Corp. | LLL | Class II | |
| K980516 | Regent Biogel Orthopedic Surgical Glove | London International Group, Inc. | KGO | Class I | |
| K980507 | Prospect Shiga Toxin Microplate Assay | Alexon - Trend, Inc. | GMZ | Class I | |
| K980376 | The Complexed Psa Assay for the Bayer Immuno 1 System | Bayer Corp. | LTJ | Class II | |
| K980227 | Manan Galactography Kit | Medical Device Technologies, Inc. | FMI | Class II | |
| K980059 | Seraquest Mumps Igg | Quest Intl., Inc. | LJY | Class I | |
| K974747 | Cs/3 Arrhythmia Workstation | Datex-Engstrom, Inc. | DSI | Class II | |
| K974424 | Comfort Rubber Gloves Industries Sdn Bhd | Comfort Rubber Gloves Industries Sdn Bhd | LYY | Class I | |
| K965212 | Steritec Disposable Integrator Load Challenge-Steam | Steritec Products Mfg. Co., Inc. | JOJ | Class II | |
| K981318 | Dual Luer Lock Cap | Baxter Healthcare Corporation | FPA | Class II | |
| K981258 | Manan Malecot Basket Drainage Catheter | Medical Device Technologies, Inc. | FEW | Class II | |
| K981229 | Manan Manta Catheter Fixation Disk | Medical Device Technologies, Inc. | KNY | Class II | |
| K981142 | Maico Ma53 | Bernafon-Maico, Inc. | EWO | Class II | |
| K980851 | Galaxy Intravascular Ultrasound System, Model I5028 | Boston Scientific Corporation | IYO | Class II | |
| K980795 | Urological Balloon Dilatation Catheter | Boston Scientific Corporation | EZN | Class II | |
| K980634 | Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted) | Aspect Vision Care, Ltd. | LPL | Class II | |
| K974598 | Microkeratome or the Mate | Howard Instruments, Inc. | HNO | Class I | |
| K981339 | Quickcheck Lyophilized Chemistry Control Conformance Chemistry Control C3 | Consolidated Technologies, Inc. | JJY | Class I | |
| K981220 | System 7500 Abc Electrosurgical Unit | Aspen Laboratories, Inc. | GEI | Class II | |
| K981090 | Laserlite Diode Surgical Laser | Laserlite, LLC | GEX | Class II | |
| K981039 | Powderfree Green Nitrile Examination Gloves (Polymer Coated) | Sri Johani Sdn. Bhd. | LZA | Class I | |
| K981035 | Pro-Vent, Pulsator Arterial Blood Sampling Syringes | Abbott Medical | JKA | Class II | |
| K980898 | Femostop II Disposable Set, Femostop II Compression Arch, Femostop II Pump, Femostop II Bilateral Adapter | Radi Medical Systems AB | DXC | Class II | |
| K980875 | Il Test Protein C | Instrumentation Laboratory Co. | GGP | Class II | |
| K980855 | Immulite 2000 Carcinoembryonic Antigen (Cea) Kit | Siemens Healthcare Diagnostics Inc. | DHX | Class II | |
| K980853 | Cedia Dau Multi-Drug Calibrators | Boehringer Mannheim Corp. | DKB | Class II | |
| K980783 | Simplex Saliva Absorber/collector, Model Ssa-5 | Irt Management Corp. | KHR | Class I | |
| K980770 | Hdl Uni-Paks (Pta), Catalogue Number 215-51 | Sekisui Diagnostics P.E.I. Inc. | LBR | Class I | |
| K980757 | Ilab 600 Clinical Chemistry System | Instrumentation Laboratory Co. | CGZ | Class II | |
| K980667 | Infinity Cholesterol Reagent (Procedure No. 401) | Sigma Diagnostics, Inc. | CHH | Class I | |
| K980465 | Olympus Tjf-140R/jf-140R Evis Duodenovideoscopes and Accessories, Olympus Maj-311/Maj-411 Distal Covers | OLYMPUS Corporation of the Americas | FDT | Class II |