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 |
|---|---|---|---|---|---|
| K933491 | R and D Batteries, Inc. Part Nos. 5038 & 5347 | R & D Batteries, Inc. | ETN | Class II | |
| K933374 | Niti Coil Springs | G & H Wire Company | DZC | Class I | |
| K932252 | Affinity Hollow Fiber Oxygenator | Avecor Cardiovascular, Inc. | DTZ | Class II | |
| K931795 | Telerad Stat | Magnetic Research, Inc. | LMD | Class I | |
| K931324 | Orbiter 922 Clinical Audiometer | Madsen Electronics (Canada), Ltd. | EWO | Class II | |
| K930752 | Ct/mri Topographic Marker | I.Z.I. Corp. | JAC | Class I | |
| K926424 | Cortical Surf Epilepsy Elect Depth Elec Epilep Mon | Radionics, Inc. | GYC | Class II | |
| K926348 | Sc1000 Scan Converter | Perkins Mfg. Co. | LMB | Class I | |
| K925956 | Microselectron - Hdr for Mobile Environment | Nucletron-Oldelft Corp. | JAQ | Class II | |
| K925234 | Bedside Caddy | Researched, Novel Medical Devices (Rn/Md) | FMI | Class II | |
| K935044 | Easyflow Airway Adapter | Easyflow Airway Systems, Inc. | CAI | Class I | |
| K934782 | Ammex Tubing Organizer | Ammex Cardiopulmonary Corp. | KRI | Class I | |
| K934725 | Phx Technologies Corp., Isds-2000, Irrigation Solution Delivery System | Phx Technologies Corp. | GCJ | Class II | |
| K934337 | Cuda Products Corp. Model Mx2-300 Lightsource | Cuda Products Co. | FSW | Class II | |
| K934141 | Stand Alone Cystometrogram | Medical Engineering Corp. | FEN | Class II | |
| K934076 | Phx Technologies Corp., Irrigation Solution Delivery System, Isds-1000 | Phx Technologies Corp. | GCJ | Class II | |
| K933192 | Access Surgical Int'l Inc. Endoscopic Surg. Inst. | Access Surgical Intl., Inc. | GCJ | Class II | |
| K931399 | Perry Enhanced Protection Latex Surgical Glove | Smith & Nephew Perry | LYY | Class I | |
| K931284 | Microdyne Office Surgical Microscope | Microdyne, Inc. | EPT | Class I | |
| K931210 | Intermedics Orthopedics Saw Blade | Intermedics Orthopedics | GFA | Class I | |
| K931179 | Urolab Spectrum | Life-Tech Intl., Inc. | FAP | Class II | |
| K931153 | Elper(tm) Barrier Integrity Monitoring | Igea, S.r.l. | LDQ | ||
| K930526 | Intermittent Compression System Model 5000 | Advanced Instruments, LLC | JOW | Class II | |
| K924071 | Integron Surgical Gloves | BD Becton Dickinson Vacutainer Systems Preanalytic | KGO | Class I | |
| K934945 | Flowmeter Nipple Adaptor | Cardio Search, Inc. | CCN | Class I | |
| K934611 | Sto2p | Ivoclar North America, Inc. | EBF | Class II | |
| K933957 | Dilating Urethral Sound | Cook Incorporated | FAH | Class II | |
| K933656 | Jedental Psrofill Self-Cure Composite | Jedental Co., Inc. | EBF | Class II | |
| K932778 | Boehringer Mannheim Es 300 Al(autoloader) Analyzer | Boehringer Mannheim Corp. | JJQ | Class I | |
| K932179 | Model 400/450 Electrolyte Analyzer | Ionetics, Inc. | JGS | Class II | |
| K930812 | Apr Femoral Hip Component | Intermedics Orthopedics | JDI | Class II | |
| K930746 | Synthetic Absorbable Surgical Suture | United States Surgical, A Division of Tyco Healthc | GAM | Class II | |
| K930456 | Intherm Single-Stick Radially Expanding Dilator | Interventional Therapeutics Corp. | KNT | Class II | |
| K926220 | T3 Uptake Chemiluminescence Assay | Nichols Institute Diagnostics | KHQ | Class II | |
| K924681 | Glutaraldehyde Monitors | Pymah Corp. | JOJ | Class II | |
| K934361 | Olympus Creatinine Reagent | Olympus Corp. | CGX | Class II | |
| K934039 | Intersect Systems Hdl Cholesterol Reagent Set | Intersect Systems, Inc. | LBR | Class I | |
| K934012 | Ft4 Radioimmunoassay | IMMUNOTECH s.r.o. | CEC | Class II | |
| K933893 | Vision Prophy Paste without Fluoride | Block Drug Company, Inc. | EJR | Class I | |
| K933885 | Alamar Biosciences Laboratory, Inc. Antimicrobial Susceptibility Test Panel | Alamar Biosciences, Inc. | JWY | Class II | |
| K933849 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K933425 | Ammonia/ethanol Controls, High/low, Cat.# A7937/7812 | Sigma Diagnostics, Inc. | DKC | Class I | |
| K933377 | Stainless Steel Arches Repacker Relabeter | G & H Wire Company | DZC | Class I | |
| K932649 | Pharmafeed | Plasco, Inc. | KPE | Class II | |
| K932631 | Xenon Light Source Illuminator | Stephen Chakoff, Inc. | GCJ | Class II | |
| K932629 | Fiber Optic Light Cable | Stephen Chakoff, Inc. | GCJ | Class II | |
| K932572 | Digital Baby Scale Model Blb-12 | Tanita Corp. of America | FRW | Class I | |
| K932369 | Uropaper Eiken 7 | Tanabe U.S.A., Inc. | JIL | Class II | |
| K932367 | Uropaper Eiken 8 | Tanabe U.S.A., Inc. | JIL | Class II | |
| K932364 | Uropaper Eiken Gp | Tanabe U.S.A., Inc. | JIL | Class II |