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 |
|---|---|---|---|---|---|
| K944969 | Steri-Lub Lubrication Gel | Horizon Medical, Inc. | KMJ | Class I | |
| K944962 | Branemark System 17 Angulated Abutment | Nobelpharma USA, Inc. | DZE | Class II | |
| K944390 | R&d Batteries Part Nos. 5141, 5067, 5118, 5277 | R & D Batteries, Inc. | FCO | Class I | |
| K943910 | Biafine | Laboratoire Medix | MGQ | Unclassified | |
| K943905 | Pro-Crylic Resin, Technicolor Pre-Mix Monomer | Professional Positioners, Inc. | EBI | Class II | |
| K943773 | Sterile Water | MEDLINE INDUSTRIES, LP - Northfield | JOL | Class II | |
| K943385 | Clinitron Elexis | Ssi Medical Services, Inc. | INX | Class II | |
| K943162 | Lake Stagezero(tm) Air Flotation Bed | Lake Medical Products, Inc. | FNM | Class II | |
| K942973 | Hasson Stabilizing Access Cannula (Sac) | Entec Corp. | HET | Class II | |
| K942905 | Disposable Temperature Probe Cover | Arbo Medical, Inc. | FMT | Class II | |
| K942870 | Ultima 2 Dental Chair | Dentech Corp. | KLC | Class I | |
| K942229 | Motivator Ftr 2000 | Hogan & Hartson | IKK | Class II | |
| K941033 | Physio Hab | Longo Industries | ISD | Class II | |
| K934804 | Puritan-Bennett Companion 320 I/e | Medtronic, Inc. | BZD | Class II | |
| K950574 | Needle/cannula | Tri-Med Specialties, Inc. | LRO | Class II | |
| K950505 | 50Mm Handpiece | PLC Medical Systems, Inc. | GEX | Class II | |
| K950503 | Manual Surgical Instrument for General Use | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | |
| K950338 | Karl Storz Rhino-Pharyngo-Laryngo-Fiberscope, Biopsy, Grasping Forceps | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K950248 | Laserspray(tm) | Biolase MG LLC | GEX | Class II | |
| K950193 | Philippe Charriol | Philippe Charriol Dist., Inc. | HQY | Class I | |
| K946029 | Acs Guide Wires with Modified Package Insert | Advanced Cardiovascular Systems, Inc. | DQX | Class II | |
| K945943 | Cvd Periflow(tm) Balloon Dilatation Catheter | Cardio-Dynamics, Inc. | LIT | Class II | |
| K945822 | Capno-Flo(tm) Regulator | Kirk Specialty Systems | CBP | Class II | |
| K945648 | Accu-Beam C02 Laser Handpiece | Tti Medical | GEX | Class II | |
| K945178 | Touch Focus 200Mm Defocusing Handpiece | PLC Medical Systems, Inc. | GEX | Class II | |
| K945012 | Catco Nutritional Catheter | Catco Medical, Inc. | KNT | Class II | |
| K944896 | Matrics Impression Material , System | Matrics, Inc. | ESD | Class I | |
| K944753 | Sensititre Susceptibility Enterococcal Vanco Amp | Radiometer America, Inc | JWY | Class II | |
| K944522 | Morganstern Prostate Stabilization and Seeding Kit | Medical Device Technologies, Inc. | IWJ | Class I | |
| K944322 | At&t Image Solutions Picasso Still-Image Phone System | At&T Image Solutions | LMD | Class I | |
| K943715 | Vision System Upper G.i. Exdoscope | Cogentix Medical, Inc. | FDS | Class II | |
| K943451 | Ultimax Powder Free Examination Gloves | Wembley Rubber Products (M) Sdn Bhd | LYY | Class I | |
| K942658 | Neoscreen Elisa Tsh | Pantex, Div. Bio-Analysis, Inc. | JLW | Class II | |
| K942454 | Datascope 95 and 97 Iab Pump Console | Datascope Corp. | DSP | Class II | |
| K942208 | 4003 Aerolite | Medical Industries America, Inc. | CAF | Class II | |
| K942020 | Sunglasses | Hopper Radio Corp. | HQY | Class I | |
| K941917 | Fluoroplua Cardiac And/or Instaview | Fidelity Medical, Inc. | JAA | Class II | |
| K940240 | Ikaros | Metasystems GmbH | LNJ | Class II | |
| K940050 | Focus EMG | Fasstech | HCC | Class II | |
| K940037 | I.d. and Seakem Gtg Agaroses | Fmc Corp. | JZR | Class I | |
| K936295 | Comfit Blue Powered Examination Gloves (Hypoallergenic) | Wembley Rubber Products | LYY | Class I | |
| K934787 | Silicore Semi-Floater | Electro-Catheter Corp. | LDF | Class II | |
| K932903 | EKG Vest | Cardiotronics, Inc. | DRX | Class II | |
| K921597 | Cavh/cvvh/cavhd Set Model #Ht-Hf/505 | Haemotronic, Inc. | FJK | Class II | |
| K950500 | Basic Reusable Trocar System | Endoscopic Concepts, Inc. | GCJ | Class II | |
| K950347 | Leveen Needle Electrode(tm) | Radiotherapeutics Corp. | GEI | Class II | |
| K946022 | Hichem Ldh/l Reagent Kit | Hichem Diagnostics | CFJ | Class II | |
| K945862 | Endcup | Lewtek | GCJ | Class II | |
| K945266 | Optus Laparoscopes and Operating Laparoscopes | Optus, Inc. | GCJ | Class II | |
| K945114 | Visitec Scleral Plug | Visitec Co. | LXP | Class II |