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 |
|---|---|---|---|---|---|
| K982134 | Dynamic Hollow Fiber Dialyzer Ds-Series Model as-851 | Dynamic Technology Corp. | KDI | Class II | |
| K990983 | Modification to Imtec Sendax Mdi | Imtec Corp. | DZE | Class II | |
| K990845 | Modification to Parts Numbered Cgt-Sl and Cgt-Sl-15 | Advanced Spine Fixation Systems, Inc. | KWP | Class II | |
| K990711 | Codan Chemospike | Codan US Corp. | LHI | Class II | |
| K990449 | Hemochron Electronic System Verification Tube | Accriva Diagnostics, Inc. | JPA | Class II | |
| K990418 | Ontrak Testcup-Er M2k | Roche Diagnostics GmbH | DKZ | Class II | |
| K990395 | Barrier Surgical Gowns | Johnson & Johnson Medical, Div. of Ethicon, Inc. | FYA | Class II | |
| K990231 | Wiltek Hot Biopsy Forceps | Wiltek Medical, Inc. | KGE | Class II | |
| K990172 | Tetraone System for Epics Xl Flow Cytometry Systems with Cyto-Stat Tetrachrome Cd45-Fitc/cd4-Rd1/cd8-Ecd/cd3-Pc5 Monocla | Coulter Corp. | GKZ | Class II | |
| K990170 | Holter 2000 | Zymed Medical Instrumentation | MLO | Class II | |
| K983892 | Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for Coaguchek Pro System, Coaguchek P | Roche Diagnostics/Boehringer Mannheim GmbH | JPA | Class II | |
| K983461 | Uni-Flex Resin | Trans-Atlantic Dental | EBI | Class II | |
| K990861 | Wound Dressing/abd Pad, Model #10810 | Hospital Specialty Co. | NAD | Class I | |
| K990813 | Rehcor | Electromed, Inc. | ISD | Class II | |
| K990370 | Msb (Electrical Stimulation) Electrodes (Disposable). (Tens/fes/nmes) | Msb,Uk | GXY | Class II | |
| K990224 | Labtician Lid Load External Eyelid Sizing Set | Labtician Ophthalmics, Inc. | MML | Class II | |
| K990129 | Tl250 Interferential/muscle Stimulator Interferential Current Therapy Muscle Stimulator | Therapy Link, Inc. | LIH | Class II | |
| K990123 | Pvr-100/Vasogram | Vasocor, Inc. | JOM | Class II | |
| K984056 | Ltv 1000 | Pulmonetic Systems, Inc. | CBK | Class II | |
| K983102 | Cardiac Diagnostic System Model Ch 2000 | Cambridge Heart, Inc. | DQK | Class II | |
| K982722 | Ambu Medibag Adult, Ambu Medibag Infant/child | Ambu, Inc. | CAF | Class II | |
| K990827 | Microplate Neonatal Galt Assay | Bio-Rad | KQP | Class II | |
| K990543 | Brightway Brand Polymer Coated Latex Examination Glove (Powder Free) | Brightway Holdings Sdn. Bhd. | LYY | Class I | |
| K990542 | Brightway Brand Nitrile Examination Glove (Lightly Powdered) | Brightway Holdings Sdn. Bhd. | LZA | Class I | |
| K990541 | Brightway Brand Nitrile Examination Glove (Powder Free) | Brightway Holdings Sdn. Bhd. | LZA | Class I | |
| K990540 | Brightway Brand Latex Examination Glove (Low Protein) | Brightway Holdings Sdn. Bhd. | LYY | Class I | |
| K990539 | Brightway Brand Latex Examination Gloves (Powder Free) | Brightway Holdings Sdn. Bhd. | LYY | Class I | |
| K990363 | Biomesh Biodegradable Gtr Barrier | Samyang Corp. | NPK | Class II | |
| K990277 | O-Ring Abutment | BioHorizons Implant Systems Inc | DZE | Class II | |
| K990082 | Epic Spo2 Finger Sensor, Model E403-09, E412-09 and Epic Oximeter Cable, Model E710-09 | Epic Medical Equipment Services, Inc. | DQA | Class II | |
| K984389 | Top Wholesome Face Mask | Top Wholesome Enterprise Co., Ltd. | FXX | Class II | |
| K984337 | Elastylon Powder-Free Surgical Glove | Eci Medical Technologies, Inc. | KGO | Class I | |
| K984059 | Angiocath Autoguard Catheter, Insyte Autoguard Catheter | BD Becton Dickinson Vacutainer Systems Preanalytic | FOZ | Class II | |
| K982617 | Tracer | Heartland Medical Systems, Inc. | MWJ | Class II | |
| K982137 | Blease Frontline Genius Range Anaesthesia Machine | Blease Medical Equipment, Ltd. | BSZ | Class II | |
| K990984 | Vitros Immunodiagnostic Products Cea Range Verifiers | Ortho-Clinical Diagnostics, Inc. | JJX | Class I | |
| K990544 | Trx-Cg Power Tilt and Recline System | Motion Concepts LP | ITI | Class II | |
| K990302 | Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to Acl Futura) | Instrumentation Laboratory Co. | GIR | Class I | |
| K984526 | Acuseal Cardiovascular Patch | W. L. Gore & Associates, Inc. | DXZ | Class II | |
| K984227 | Omega II Modular Total Hip System | Osteoimplant Technology, Inc. | JDI | Class II | |
| K982940 | Lightsheer Pulsed Diode Array Laser System | Star Medical Technologies, Inc. | GEX | Class II | |
| K982365 | Atraumatic Vascular Clamps, Model #'S 22-Xxxx, 23-Xxxx, 03-60Xx, 25-Xxxx Micro Vascular Clamps Model # 75-0Xxx, Atraumat | Geister Medizin Technik GmbH | DXC | Class II | |
| K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound System and Transducers | Medison America, Inc. | IYN | Class II | |
| K990888 | Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752 | Bio-Rad | JJY | Class I | |
| K990587 | Abbott Liquid RF Control, Models 2E04-01, 2E05-01, 2E06-01 | Bio-Rad | DHR | Class II | |
| K990262 | Clearplan Easy Home Pregnancy Test | Unipath, Ltd. | LCX | Class II | |
| K983919 | Ems Mouth to Mask Resuscitators | Engineered Medical Systems, LLC | CBP | Class II | |
| K981668 | Smartvent 201 Portable Ventilator | Versamed, Ltd. | CBK | Class II | |
| K981191 | Iti Intramax Guide Catheter 91, 78 and 65 | Intratherapeutics, Inc. | DQY | Class II | |
| K990898 | Prodigy 4 | Sybron Dental Specialties, Inc. | EBF | Class II |