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 |
|---|---|---|---|---|---|
| K874401 | Titanium Suction Tip | Implant Innovations International, Inc. | EHZ | Class I | |
| K874325 | Model a-72, Behind-the-Ear Hearing Aid | Audiotone, Inc. | ESD | Class I | |
| K873886 | Clearfil Porcelain Repair System | Kuraray Co. | EBF | Class II | |
| K873784 | Nova Strep a | Synbiotics Corp. | GTZ | Class I | |
| K873686 | Diamond-Luster Dental Polishing Paste | Scientific Pharmaceuticals, Inc. | EJR | Class I | |
| K873597 | Tubing, Polyethylene | Coeur Laboratories, Inc. | DXT | Class II | |
| K873490 | Hearing Aid (All-in-the-Ear) | Kerr Hearing Aid Laboratory | ESD | Class I | |
| K864299 | Novo Bmc-Lab 23, Bone Densitometer | Scan Detectronic Laboratories, Inc. | KGI | Class II | |
| K874291 | Epi-Lock T.m. Primaderm | Derma-Lock Medical Corp. | NAD | Class I | |
| K873246 | Model 5001 Micromanipulator for Use W/tf-25 CO2 | Coherent Medical Group | GEX | Class II | |
| K874101 | Emds N-Acetylprocainamide Calibrator #67635/95 | Em Diagnostic Systems, Inc. | DLJ | Class II | |
| K873361 | Life-Span Cable | Chemfet Corp. | IKD | Class II | |
| K872935 | Anti-Infection Shield | Stackhouse Assoc. | FXX | Class II | |
| K871327 | D.r.p. Three Step Wound Dressing | Bioderm, Inc. | FRO | Unclassified | |
| K874454 | IV-Push, Constant Infusion Pump | Medical Products Search, Inc. | KZD | Class I | |
| K874404 | Hi-Lo Temp(r) Skin Temperature Sensor | Mallinckrodt Critical Care | FLL | Class II | |
| K874372 | Hr(tm) Needle and Syringe | Abbott Medical | FMI | Class II | |
| K874345 | Tsa W/neomycin & 5% Sheep Blood - # P3104 & Z3050 | Lakewood Biochemical Co., Inc. | JSJ | Class I | |
| K874344 | Quad Plate (4 Different Media) | Lakewood Biochemical Co., Inc. | JSI | Class I | |
| K874303 | Staphylase Test | Oxoid U.S.A., Inc. | LHT | Class I | |
| K874300 | Aesthesiometer | Mizuho Orthopedic Systems Inc | GWI | Class I | |
| K874118 | Model 410 Dental X-Ray Film Processors | Dent-X Co. | EGY | Class II | |
| K874088 | Easy-Test Creatinine (Crea) Item No. 19009 | Em Diagnostic Systems, Inc. | CGX | Class II | |
| K874036 | Model 7000 Combination End Tidal & Pulse Oximetry | Novametrix Medical Systems, Inc. | CCK | Class II | |
| K874023 | Levtech Clamp Applier | Levtech, Inc. | HTD | Class I | |
| K873923 | Integrated Membrane Oxygenator W/cardiotomy Filter | American Bentley | DTZ | Class II | |
| K873813 | Sarns Warmer, Part #164975 and #164980 | 3M Health Care, Sarns | DWC | Class II | |
| K873802 | Pressure Barrier Kit Cat. No. Pbk-3 | American Omni Medical, Inc. | DXS | Class II | |
| K873774 | M300 Monitor/controller T500 Treadmill | Burdick Corp. | DXJ | Class II | |
| K873767 | Humid-Vent(r) Mini | Gibeck Respiration | BYD | Class I | |
| K873745 | Bair Hugger(tm) - Patient Warming System | Augustine Medical, Inc. | DWJ | Class II | |
| K873664 | Light-Spot Fiberoptic Laser Handpiece | Laserguide | GEX | Class II | |
| K873571 | Light-Touch Fiberoptic Microcontact Probe | Laserguide | GEX | Class II | |
| K873466 | Excel Pulsed Irrigation/suction System | Stryker Corp. | FQH | Class II | |
| K873461 | Laser-Flex(tm) Tracheal Tube (Cuffed) | Mallinckrodt Critical Care | BTR | Class II | |
| K873423 | Maxima* Collapsible Venous Reservoir Bag & Holder | Johnson & Johnson Professionals, Inc. | DTN | Class II | |
| K873359 | Airlife Volume Venti. Circuit W/clear Cap Ex Valve | American Pharmaseal Div. Ahsc | CAI | Class I | |
| K873271 | Digicell 300 System | Contraves Medical Instruments, Inc. | GKL | Class II | |
| K873260 | Corynebacteria Isolation Media | Central Media | JSI | Class I | |
| K873259 | Specialty Media | Central Media | JSI | Class I | |
| K873258 | Streptococcal Selective Differen. & Enriched Media | Central Media | JSI | Class I | |
| K873257 | General Purpose Media W/select. & Diff. Modifica. | Central Media | JSG | Class I | |
| K873256 | Micro-Count Diffhe | Toni Diagnostics, Inc. | GKZ | Class II | |
| K873252 | Digicell 500 | Contraves Medical Instruments, Inc. | GKL | Class II | |
| K873212 | Sarns Cardioplegia/vent Catheters | 3M Health Care, Sarns | DWF | Class II | |
| K873172 | Hamilton-Thorn Motility Analyzer Htm-2000 | Hamilton Thorne Research | GKL | Class II | |
| K873149 | Novametrix End Tidal CO2 Monitor, Model 1260 | Novametrix Medical Systems, Inc. | CCK | Class II | |
| K871697 | Genesis II | Biosound, Inc. | DXK | Class II | |
| K871198 | Bone Marrow Collection Kit and Stand | Baxter Healthcare Corporation | LWE | Class II | |
| K870885 | Medtronic Model 5513 Endocardial Pacing Lead | Medtronic, Inc. | DTB | Class III |