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 |
|---|---|---|---|---|---|
| K913382 | Mega Paracentesis Kit | Mega Medical, Inc. | KKX | Class II | |
| K913259 | Nova Celltrak 12 Auto Multi-Para Hema Analyzer/cal | Nova Biomedical Corporation | GKZ | Class II | |
| K913178 | Acs Vsw Guide Wire | Advanced Cardiovascular Systems, Inc. | DQX | Class II | |
| K913127 | Coherent Novus 3000 Argon Photocoagulator | Coherent Medical Group | GEX | Class II | |
| K913109 | Lateralase(tm) Catheter with Thermal Feedback | Trimedyne, Inc. | GEX | Class II | |
| K913059 | A-Dec Kneebreak 1030 Chair | A-dec, Inc. | KLC | Class I | |
| K912737 | Medarmor Fingertip, Punc/cut Resist Surg Exam Glov | Medical Armor Corp. | LYU | Class I | |
| K912161 | i.v. Starr Kit | Medical Device Inspection Company | LKB | Unclassified | |
| K912111 | Modified Version Implantable Vascular Access Syste | Gerard Medical Enterprises, Inc. | FMF | Class II | |
| K912019 | Orthofuser Wound Drainage/autotransfusion System | Gish Biomedical, Inc. | CAC | Class II | |
| K911962 | Bird Sentry Air/oxygen Microblender | Bird Products Corp. | BZR | Class II | |
| K911231 | Orthodontic Wire | Masel Industries, Inc. | EJF | Class I | |
| K902401 | Celsite(tm) Implantable Drug Delivery System | Burron Medical, Inc. | FMF | Class II | |
| K914187 | Ambu Silicone Resuscitator Infant/child | Ambu, Inc. | BTM | Class II | |
| K914168 | Augustine Guide Kit with Gauze Sponge | Augustine Medical, Inc. | CCW | Class I | |
| K913901 | Freedom Wheels Az 100 | Arizona Freedom Wheels, Inc. | ITI | Class II | |
| K913184 | Ms-III Ministim | Life-Tech Intl., Inc. | BXN | Class II | |
| K913040 | Ribbond(tm) | Ribbond, Inc. | EBI | Class II | |
| K912698 | Affinity Free T4 Test System | BD Becton Dickinson Vacutainer Systems Preanalytic | CEC | Class II | |
| K912383 | Vibratouch II Cordless Wand Massager | Conair LLC. | ISA | Class I | |
| K911785 | Rhino-Guard | Micromedics, Inc. | CAF | Class II | |
| K911362 | Amizyme Epstein-Barr Virus (Ebv) Igm Antibody Test | Amico Laboratories, Inc. | LJN | Class I | |
| K911044 | 7.5 Mhz Apas Transducer (Art.nol: 50.04918.1) | Pie Medical Equipment B.V. | ITX | Class II | |
| K910503 | Discography Kit | B. Braun of America, Inc. | IZG | Class II | |
| K903313 | Rahd 3100 | Esm, Ltd. | KPQ | Class II | |
| K900623 | Zimmon Esophago-Gastric Balloon Tamponade Device | Wilson-Cook Medical Inc. | KNT | Class II | |
| K913883 | Cox Disposable Biopsy Forcep | Cox Medical Ent., Inc. | FCL | Class I | |
| K913991 | Grasper, Ratcheted (5Mm X 30Cm) | Northgate Technologies Inc. | GCJ | Class II | |
| K913930 | Fixation Devices and Bone Plate | John M. Rayhack | HRS | Class II | |
| K913800 | Meda Crown Series | Medical Electronic Assn. | GZJ | Class II | |
| K913700 | Disposable Bouffant Cap | Gem Nonwovews, Inc. | FYF | Class I | |
| K913628 | Disposable Shoe Cover | Gem Nonwovews, Inc. | FXP | Class I | |
| K913567 | Wellprep 1 | Denley Instruments, Inc. | JQW | Class I | |
| K913543 | Thoracic Catheter Stylet | Intl. Medical Devices, Ltd. | DRB | Class II | |
| K913537 | Memosil C.d. | Kulzer GmbH | ELW | Class II | |
| K913524 | Silicone Male External Catheter | Mentor | EXJ | Class I | |
| K913294 | Surgitek(r) Laparoscopic Cholangiogram Kit | Surgitek Medical Engineering Corp. | GCA | Class II | |
| K913038 | Spacelab Model 90845 Pcms Multidisclosure Station | Spacelabs, Inc. | DSH | Class II | |
| K912979 | Hemawipe System, the Civilized Test, Modification | Labeltape Meditect, Inc. | KHE | Class II | |
| K912957 | Concept Micromill | Concept, Inc. | HRX | Class II | |
| K912952 | Bandage Compress | Cal West Trading Co. | NAB | Class I | |
| K912950 | Compress Dressing | Cal West Trading Co. | NAB | Class I | |
| K912922 | Dimension-Ha Hip Prosthesis | Kirschner Medical Corp. | MEH | Class II | |
| K912741 | Elite R 90/15 | Fischer Imaging Corp. | IXR | Class II | |
| K912693 | Post Operative Sponge | Ulti-Med Intl., Inc. | NAB | Class I | |
| K912692 | Conforming Bandage | Ulti-Med Intl., Inc. | NAB | Class I | |
| K912637 | Laparoscopic Electrosurgical Cannula W/retractable | Dexide, Inc. | GEI | Class II | |
| K912457 | Medarmor Fingertip, Puncture and Cut Resistant Glo | Medical Armor Corp. | LYU | Class I | |
| K912452 | Ha Mccutchen Slt Hip System | Dow Corning Wright | MEH | Class II | |
| K912215 | Pyloritrak | Bainbridge Laboratories, Inc. | LYR | Class I |