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 |
|---|---|---|---|---|---|
| K870713 | Multi-Flex Table -- Model 104 | Slenderizers Equipment Mfg., Inc. | JFB | Class II | |
| K870712 | Multi-Flex Table -- Model 103 | Slenderizers Equipment Mfg., Inc. | JFB | Class II | |
| K870711 | Multi-Flex Table -- Model 102 | Slenderizers Equipment Mfg., Inc. | JFB | Class II | |
| K870710 | Multi-Flex Table -- Model 101 | Slenderizers Equipment Mfg., Inc. | JFB | Class II | |
| K861730 | Actril for Kidney Machine Disinfectant | Renal Systems, Inc. | FKQ | Class II | |
| K872017 | Bte Hearing Aid Oticon Model E30p | Oticon, Inc. | ESD | Class I | |
| K871885 | Eska-Herrmann Tracheostomy Valve | C.R. Bard Inc | EWL | Class II | |
| K871851 | Ribbed Cushion Mask | Engineered Medical Systems, LLC | BSJ | Class I | |
| K871680 | Modified Cobas Fp Reagents for Napa and Calibrator | Roche Diagnostic Systems, Inc. | LAN | Class II | |
| K871648 | Tmj Cannula Set | Aspen Laboratories, Inc. | DZI | Class II | |
| K871569 | Modified Heart*aid 97 Auto. External Defibrillator | Cardiac Resucitator Corp. | DRO | Class II | |
| K871520 | Telstar Model Fs Hearing Aid | Telstar Electronics, Inc. | ESD | Class I | |
| K871439 | Cosmetic Single Span Bridge | Cosmetic Dental Technologies, Inc. | EGG | Class I | |
| K871353 | Oximeter | Radiometer America, Inc | DQA | Class II | |
| K871350 | Prebypass Filter | American Omni Medical, Inc. | KRJ | Class II | |
| K871325 | Bowen Reuseable/disposable Electrode | Bowen & Company, Inc. | DRX | Class II | |
| K871300 | Vip's Prophylactics, Natural, Anatomic & Femina | Professional Pharmacy West, Inc. | HIS | Class II | |
| K871199 | Modified Pertrach Disp. Pediatric Percut. Tracheo. | Frederic J. Toye, M.D. | BTO | Class II | |
| K871072 | Omega Nasal Septal Button | Omega Silicone, Inc. | LFB | Unclassified | |
| K870819 | Bubble Trap Cat. No. B-180 | American Omni Medical, Inc. | DWF | Class II | |
| K870405 | Dsl Estradial Radioimmunoassay (Dsl-4400) | Diagnostic Systems Laboratories, Inc. | CHP | Class I | |
| K870280 | Accudent Accuprobe | Accudent, Inc. | EIX | Class I | |
| K871980 | D-23 Denture Adhesive | Solar Dental Co., Inc. | KOJ | Class II | |
| K871976 | Multichem Glucose Hexokinase Reagent #S0919 | Simmler Inc | CFR | Class II | |
| K871975 | Multichem Total Protein Reagent #S0928 | Simmler Inc | CEK | Class II | |
| K871937 | Impression Syringe | Dentsply Intl. | EID | Class I | |
| K871891 | Karl Storz Model 28184 Pneumatic Shuttle Shaver | Karl Storz Endoscopy-America, Inc. | HSZ | Class I | |
| K871861 | Implantable Programmable Cardiac Pulse Generators | Telectronics, Inc. | DXY | Class III | |
| K871808 | Duceram-Metal-Ceramic Dental Porcelain System | Degussa Dental, Inc. | ELL | Class II | |
| K871793 | Lido Active | Loredan Biomedical, Inc. | IKK | Class II | |
| K871753 | Master Medical Device Is i.v. Stat 2 | The Master Medical Corp. | FPA | Class II | |
| K871719 | Modified Model Ua-751 Digital Sphygmonometer | A and D Engineering, Inc. | DXN | Class II | |
| K871717 | Model 28200C Micro-Arthroplasty System | Karl Storz Endoscopy-America, Inc. | HWE | Class I | |
| K871696 | Double Antibody Amphetamine Kapd1 and Kapd5 | Siemens Healthcare Diagnostics Inc. | DKZ | Class II | |
| K871695 | Double Antibody Cannabinoids Kthd1 and Kthd5 | Siemens Healthcare Diagnostics Inc. | LDJ | Class II | |
| K871626 | Electrotrace Disp Rest EKG Electrode, Cat. Et1200 | Jason Marketing Co. | DRX | Class II | |
| K871621 | The Karl Storz Model 28805 Arthro Pump | Karl Storz Endoscopy-America, Inc. | HRX | Class II | |
| K871594 | Birthing Room Warmer | Air-Shields, Inc. | FMT | Class II | |
| K871551 | Model Number 8200 Respiration/heart Rate Monitor | Aequitron Medical, Inc. | BZQ | Class II | |
| K871522 | Telstar Model C Hearing Aid | Telstar Electronics, Inc. | ESD | Class I | |
| K871521 | Full Shell Ite Hearing Aid | Telstar Electronics, Inc. | ESD | Class I | |
| K871518 | Telstar Model F3ts Hearing Aid | Telstar Electronics, Inc. | ESD | Class I | |
| K871482 | Hypertension Risk Detector(tm) | Pearce Clinical Laboratories, Inc. | DXN | Class II | |
| K871459 | Survival Kit, Indiv Trop Tact Air Crew/plastic Bag | Frass Survival Systems, Inc. | LRO | Class II | |
| K871399 | Ohio(r) Care Plus Incubator | GE Healthcare | FMZ | Class II | |
| K871390 | Bard Biopty Biopsy System | C.R. Bard Inc | KNW | Class II | |
| K871363 | Model 420 System Measurement, Blood Pressure | Quinton, Inc. | DXN | Class II | |
| K871337 | M-2 Oxygen/temperature Monitor | Bio-Med Devices, Inc. | CCL | Class II | |
| K871336 | M-1 Pressure Monitor | Bio-Med Devices, Inc. | CAP | Class II | |
| K871305 | Cocaine Metabolite Enzyme Immunoassay Kit | General Diagnostics | DIO | Class II |