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 |
|---|---|---|---|---|---|
| K950984 | Hapes Malleable Incus Stapes | Smith & Nephew Richards, Inc. | ETB | Class II | |
| K950932 | Bipolap Hook Electrode | Berchtold Holding GmbH | GEI | Class II | |
| K950887 | Hapex Incus | Smith & Nephew Richards, Inc. | ETB | Class II | |
| K950886 | Hapex Porp | Smith & Nephew Richards, Inc. | ETB | Class II | |
| K950885 | Hapex Malleable Porp | Smith & Nephew Richards, Inc. | ETB | Class II | |
| K950438 | Safedweel Dressing Change Tray | Becton Dickinson Vascular Access, Inc. | FRG | Class II | |
| K950433 | Karl Storz Endopyelotomy Set for Endoscopic Urology Procedures | Karl Storz Endoscopy-America, Inc. | FGA | Class II | |
| K950184 | B. Braun IV Start Kits | B. Braun of America, Inc. | LRS | Class II | |
| K950180 | Dupont Dimension(r) Pseudocholinesterase Method | E.I. Dupont de Nemours & Co., Inc. | DLI | Class I | |
| K950007 | Surgical Instrument Guide | United States Surgical, A Division of Tyco Healthc | GDF | Class I | |
| K950006 | Surgical Staple Marker | Biopsys Medical, Inc. | GDW | Class II | |
| K946304 | Coherent Family of CO2 Surgical Laser Scanner Handpieces | Lumenis Ltd | GEX | Class II | |
| K945809 | Monoject(r) Vertical Entry Sharps Container (1 Qt) | Sherwood Medical Co. | FMI | Class II | |
| K944691 | Itc Whole Blood Control Normal/abnormal Level I or II | Accriva Diagnostics, Inc. | GGN | Class II | |
| K944406 | Olympus Glucose Reagent | OLYMPUS Corporation of the Americas | CFR | Class II | |
| K944329 | Back Specialist | Health Care Mfg., Inc. | INQ | Class I | |
| K943363 | Cutiplast Steril | Beiersdorf, Inc. | MGP | Unclassified | |
| K943150 | Direct Ldl Cholesterol Immunoseparation Reagent Kit | Genzyme Corporation | MRR | Class I | |
| K942900 | Osteonics Secure-Fit Ad-Ha Acetabular Component System | Osteonics Corp. | MEH | Class II | |
| K935868 | Dynaphor(tm) Two | Maxxim Medical | EGJ | Class II | |
| K934115 | 3000 Electronic Insufflator Modification | Cabot Medical Corp. | HIF | Class II | |
| K933278 | Intermedics Triangle Chest Probe Model 526-04 | Intermedics, Inc. | KRG | Class III | |
| K950953 | Karl Storz Pediatric Vancaillie Take-Apart Bipolar Micro-Forceps, Manhes Take-Apart Bipolar Forceps, Vbipolar Coagulatee | Karl Storz Endoscopy-America, Inc. | GEI | Class II | |
| K950942 | Crit-Line Hematocrit Alert | In-Line Diagnostics Corp. | JPI | Class II | |
| K950938 | Hilton, Bently Set, Senator, Mayfair Match and Monsiur | Rahddim, Inc. | HQY | Class I | |
| K950924 | Aslan Knot Pusher | Aslan Medical Technologies, Ltd. | FDE | Class II | |
| K950874 | Cardon Physical Therapy Tables Models: R27610 | Cardon Rehabilitation Products, Inc. | INQ | Class I | |
| K950850 | Gent-L-Kare Laceration Trays | Premium Plastics, Inc. | FRG | Class II | |
| K950778 | Medifriend Professional Sphygmomanometer | Shanghai Medifriend Medical Products Co., Ltd. | DXQ | Class II | |
| K950569 | Ophta Sil {Self-Threading Monoka (Ritleng Type)} | G.W.B. Intl., Ltd. | LZU | Unclassified | |
| K950439 | Insyte Sideholded Drainage Catheter | Becton Dickinson Vascular Access, Inc. | GBX | Class I | |
| K950437 | Angiocath Sideholder Drainage Catheter | Becton Dickinson Vascular Access, Inc. | GBX | Class I | |
| K950304 | Deseret (R) T-Port (R) Multi Flo(tm) and Deseret (R)prn Adapter | Becton Dickinson Vascular Access, Inc. | FPA | Class II | |
| K950303 | Deseret(r) i.v. Loop and Deseret (R) J Loop | Becton Dickinson Vascular Access, Inc. | FPA | Class II | |
| K946252 | Stereoplan | Radionics Software Applications, Inc. | HAW | Class II | |
| K946208 | Volker Nursing Bed Model 2080E & 2090E | Volker Healthcare, Inc. | FNL | Class II | |
| K946181 | Infinitech Soft Tip Flute Needle | Surgical Technologies, Inc. | HQE | Class II | |
| K946149 | Stryker Agility Intensive Care Bed | Stryker Medical | FNL | Class II | |
| K945512 | Hrsw Option for CT Twin Flash | Elscint, Inc. | JAK | Class II | |
| K945460 | Philips Cd Medical Recorder, View Station, Dup[[lication Station | Philips North America LLC | JAA | Class II | |
| K945062 | Vacplus | KCI USA, Inc. | JCX | Class II | |
| K944994 | Iolab/site Disposable Diaphragm Cassette | Chiron Vision Corp. | HQC | Class II | |
| K944442 | General Electric Amx 110, Amx II and Amx 3 | Pro-Tronics, Inc. | IZL | Class II | |
| K944437 | Disposable Laser Sweep Tip | Reliant Technologies, Inc. | GEX | Class II | |
| K943716 | Lasersonics Surgical Laser Systems and Accessories | Heraeus Surgical, Inc. | GEX | Class II | |
| K941407 | Tympanostomy (Ventilation) Tube | Xomed-Treace, Inc. | ETD | Class II | |
| K934779 | Agram Spyral Electrode | Agram Export-Import Co. | GXZ | Class II | |
| K950772 | Argelite 61 (Palladium - Silver Dental Casting Alloy for Porcelain Applications) | Argen Precious Metals, Inc. | EJT | Class II | |
| K950765 | Compa Lab-R | Robert W. Bauer & Assoc., Inc. | EBF | Class II | |
| K950302 | E-Z Set(r) and Minicath(r) Infusion Sets | Becton Dickinson Vascular Access, Inc. | FPA | Class II |