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 |
|---|---|---|---|---|---|
| K003341 | Emit 2000 Tobramycin Assay Emit 2000 Tobramycin Calibrators | Syva Co., Dade Behring, Inc. | KLB | Class II | |
| K003323 | Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205 | Davol, Inc. | FTL | Class II | |
| K003042 | V/x Aspheric Toric Multifocal (Polymacon) Soft (Hydrophilic) Lenses with a Clear or Blue Visibility Tint | Joe B. Goldberg, O.D. | LPL | Class II | |
| K002930 | Instaccult | Medtek Diagnostics, LLC | KHE | Class II | |
| K002624 | Glucosmart Blood Glucose Monitoring System | Apex Biotechnology Corp. | CGA | Class II | |
| K002621 | Glucosure Blood Glucose Monitoring System | Apex Biotechnology Corp. | CGA | Class II | |
| K002011 | Glutartest 1 Reagent Strip | Integrated Biomedical Technology, Inc. | MSY | Class II | |
| K010073 | Spline Dental Implant System | Sulzer Calcitek, Inc. | DZE | Class II | |
| K003964 | Trapease Permanent Vena Filter and Introduction Kit, Models 466-P306a and 466-P306b | Cordis US Corp. | DTK | Class II | |
| K003554 | Hardydisk Trimethoprim 5Mcg | Hardy Diagnostics | JTN | Class II | |
| K003484 | Netra Workstation and Netramd Software | Scimage, Inc. | LLZ | Class II | |
| K003481 | Codonics Np-1660 Series Medical Printers, Model 1660 | Codonics, Inc. | LMC | Class II | |
| K003422 | Edta Root Canal Cleanser | Super Glide, Inc. | KJJ | Unclassified | |
| K003368 | Acrotherm | Aquarius Medical Corp. | DWJ | Class II | |
| K003358 | Qps (Quantitative Perfusion Spect), Qgs (Quantitative Gated Spect) | Smv America | KPS | Class II | |
| K003316 | Oti Ceramic Femoral Head System | Osteoimplant Technology, Inc. | LZO | Class II | |
| K002061 | A&d Medical Tm-2550/Tm-2551/Tm-2560 Vital Sensor Monitor | A and D Engineering, Inc. | DRT | Class II | |
| K000884 | Bd Probetec Et Mycobacterium Tuberculosis Complex (Ctb) Culture Identification Assay | Becton Dickinson Biosciences | NDZ | Class I | |
| K000852 | Renew Neurostimulation System | Abbott Medical | GZF | Class II | |
| K003938 | Trak Back II | Jomed AG | DQO | Class II | |
| K003931 | Vivid 7 with Sonopac, Model Fb0008xx | GE Healthcare | IYN | Class II | |
| K003736 | MRI Line Marker | I.Z.I. Corp. | JAK | Class II | |
| K003492 | Analytic Spectral Method of Alternans Processing; Ch 2000 Cardiac Diagnostic System; Heartwave Alternans Processing Sys | Cambridge Heart, Inc. | DQK | Class II | |
| K003479 | U-Systems Ultrasound System Usi-2000 | U-Systems, Inc. | IYN | Class II | |
| K003454 | A1-Cs-Sb Y-Adapter, Model 124 871 | BIOTRONIK AG | DTD | Class II | |
| K003453 | Sympulse Computer System for Fonar MRI Scanners | Fonar Corp. | LNH | Class II | |
| K003297 | Mammotome Hand Held Probe, Model Mhh8 | Ethicon Endo-Surgery Inc | KNW | Class II | |
| K003286 | Symphony Graft Delivery System | Depuyacromed | LYC | Class II | |
| K001528 | Pc Flow + | Spirometrics Medical Equipment Co. | BZG | Class II | |
| K001097 | Active Array Catheter, Model Cs-2000 | Image-Guided Neurologics, Inc. | MOS | Class II | |
| K003928 | Townley Transfacetpedicular Screw Fixation System | Medtronic Sofamor Danek | MRW | Unclassified | |
| K003901 | Angiodynamics Soft-Vu Sizing Angiographic Catheter | Boston Scientific Corporation | DQO | Class II | |
| K003895 | X-Tenda Cuff Powder Free Latex Surgical Gloves with Protein Content Labeling Claim 50 Micrograms or Less, Model Style 21 | Ansell Perry | KGO | Class I | |
| K003751 | Hyaluronidase Reagent, Model Cat#2212 | Invitrocare Inc | MQL | Class II | |
| K003583 | Lithium Regent Model Tr66056 / Lithium Standard Tr66901 | Trace America, Inc. | NDW | Class II | |
| K003575 | Modification to 3.0T Signa Vh/i Magnetic Resonance System | GE Healthcare | LNI | Class II | |
| K003556 | Hardydisk Amoxicillin/clavulanic Acid, 20/10Mcg | Hardy Diagnostics | JTN | Class II | |
| K003508 | Nc-Stat | Neurometrix, Inc. | JXE | Class II | |
| K003393 | Maxillary Distractor | Synthes (USA) Products LLC | JEY | Class II | |
| K003284 | Phlebopump, Model 1000 | Prevent Products, Inc. | JOW | Class II | |
| K003278 | Complete Human Tubal Fluid (Htf) with Serum Substitute Supplement, Model 9922 | FUJIFILM Biosciences Inc. | MQL | Class II | |
| K003174 | Elecsys Dhea-S | Roche Diagnostics GmbH | JKC | Class I | |
| K002638 | Future Diagnostics B.v. Stat-Acth Kit | Future Diagnostics B.V. | CKG | Class II | |
| K002331 | Profile-Er | MEDTOX Diagnostics, Inc. | DIS | Class II | |
| K001283 | Lifemate Hemofiltration System | NxStage Medical Inc | KDI | Class II | |
| K003991 | Cd-Cal Plus Calibrator | R & D Systems, Inc. | KRX | Class II | |
| K003817 | Pattern Resin | GC America Inc. | EBG | Class II | |
| K003771 | Encore Powder-Free Latex Surgical Gloves, Orthopaedic with Protein Content Labeling Claim (50 Micrograms or Less) | Ansell Healthcare Products LLC | KGO | Class I | |
| K003745 | Laryngeal Surface Electrode-Endotracheal Tube, M-500-Et, Lse-Et | Rln Systems, Inc. | ETN | Class II | |
| K010027 | Maxim Knee System | Zimmer GmbH | JWH | Class II |