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 |
|---|---|---|---|---|---|
| K922667 | Mic Low Profile Gastrostomy Tube | Medical Innovations, Inc. | KNT | Class II | |
| K934723 | Argyle Aspr-Care Closed Suction System | Sherwood Medical Co. | BSY | Class I | |
| K933541 | Gore-Tex Periodontal Material - Titanium Reinforced Configurations | W. L. Gore & Associates, Inc. | NPK | Class II | |
| K932663 | Medline A/c Powered Healthcare Beds & Accessories | MEDLINE INDUSTRIES, LP - Northfield | FNL | Class II | |
| K931634 | Various Kits | Polymint Industrial Co., Ltd. | LRR | Not classified | |
| K931412 | Powder Free Examination Gloves | Chatsworth Medical Supply, Inc. | LYY | Class I | |
| K930228 | Ortholoc Advantim Tibial Stem 5 Degree | Dow Corning Wright | JWH | Class II | |
| K930167 | Reusable Towel and Gown Packs | Custom Sterile Services, Inc. | FYD | Class II | |
| K930067 | Buffalo Filter Surgical Mask | Buffalo Filter Co., Inc. | FXX | Class II | |
| K930062 | Buffalo Filter Replacement Filter #Bst300ul | Buffalo Filter Co., Inc. | FYD | Class II | |
| K930058 | Buffalo Filter Replacement Filter #Bptu100 | Buffalo Filter Co., Inc. | FYD | Class II | |
| K924141 | Orthopaedic Polyethylene Cable | Smith & Nephew Richards, Inc. | JDQ | Class II | |
| K923011 | Osteonics Unix Unicompartmental | Osteonics Corp. | HRY | Class II | |
| K935220 | Core Prevent Mattress Modification | Paladin Medical, Inc. | FMW | Class I | |
| K934565 | Unitron Model Ikon Agco/ Aod | Unitron Industries, Inc. | ESD | Class I | |
| K934417 | Omni 2000 Series Itc Hearing Aid | Starkey Laboratories, Inc. | ESD | Class I | |
| K934416 | Omni 2000 Series Ite Hearing Aid | Starkey Laboratories, Inc. | ESD | Class I | |
| K934247 | Bisco Universal Hybrid Composite | Bisco, Inc. | EBF | Class II | |
| K932787 | Batroxobin Reagent | Behring Diagnostics, Inc. | JCO | Class II | |
| K932446 | Injection Site | 3M Company | FPA | Class II | |
| K932098 | Capnomac Ultima Anesthesia Monitor | Datex Division Instrumentarium Corp. | BZK | Class II | |
| K931137 | Dental Syringe Tip | A-dec, Inc. | ECB | Class I | |
| K926478 | Gore-Tek(r) Soft Tissue Patch | W. L. Gore & Associates, Inc. | FTL | Class II | |
| K934533 | Bun-300/Bun-500 Urea Nitrogen Reagent | Horizon Diagnostics, Inc. | CDQ | Class II | |
| K934521 | Spq Malb Control Level II | Incstar Corp. | JJX | Class I | |
| K934257 | U-Trol Liquid Urine Dipstick Control | P.T. Meditrol | JJW | Class I | |
| K932686 | Paramax(r) Phenytoin Reagent | Baxter Diagnostics, Inc. | DIP | Class II | |
| K932366 | Uropaper Eiken Hag | Tanabe U.S.A., Inc. | JIL | Class II | |
| K932365 | Uropaper Eiken Ag | Tanabe U.S.A., Inc. | JIL | Class II | |
| K934396 | Quadrature Lower Extremity Coil | Medical Advances, Inc. | LNH | Class II | |
| K934369 | Dri Sleeper | Abbott Medical | KPN | Class II | |
| K934285 | Catheter Introducer Modification | Daig Corp. | DYB | Class II | |
| K934272 | Sensormedics Microgard Microbial Filter | Sensor Medics Corp. | CAH | Class II | |
| K934258 | Saline Wet Dressing- Sterile | Trinity Laboratories, Inc. | FRO | Unclassified | |
| K934190 | Hme W/o Filter Hygroflex, Hygroflex-T, Modification | Bird Life Design | BYD | Class I | |
| K934189 | Barrierflex-I, and Barrierfles-II | Bird Life Design | CAH | Class II | |
| K934180 | Slimline 3000 | Pymah Corp. | DXQ | Class II | |
| K934005 | Shimadzu Ceiling Tube Support Ch-30Gx | Shimadzu Corp. | KPR | Class II | |
| K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | FZP | Class II | |
| K933513 | R &D Batteries, Inc. Part # 5015, 5192, 5482 | R & D Batteries, Inc. | IYX | Class I | |
| K933473 | Catheterization C-Arm Support Mh-51Bm/mh-51Cm | Shimadzu Corp. | JAA | Class II | |
| K933471 | Shimadzu X-Ray High Voltage Generator Aud150g | Shimadzu Corp. | IZO | Class I | |
| K933220 | Selector Sl 01 | Futuremed Div. of Future Impex Corp. | EWO | Class II | |
| K932652 | Tri-Med Paracentesis Tray | Tri-Med Specialties, Inc. | LRO | Class II | |
| K932200 | Lspi Automatic Ventilator | Life Support Products, Inc. | BTL | Class II | |
| K932199 | Lspi Automatic Ventilator, Model Av3000 | Life Support Products, Inc. | BTL | Class II | |
| K931422 | Deltatrac(tm) II Metabolic Monitor | Datex Division Instrumentarium Corp. | BZL | Class II | |
| K924432 | Medison 1500 | Medison Co., Ltd. | IYO | Class II | |
| K922819 | Infant Disposable Bag Mask Resuscitator | Life Support Products, Inc. | BTM | Class II | |
| K922691 | Lsp (Model 554) Bag Mask Resuscitator | Life Support Products, Inc. | BTM | Class II |