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 |
|---|---|---|---|---|---|
| K952265 | Milestonw 350/450/550Hf, Pcx N350/450/550hf, Top-X 350/450/550Hf Radiographic X-Ray Generator | Control-X, Inc. | IZO | Class I | |
| K951808 | Med-Tec Redi-Foam | Medtec LLC | IYE | Class II | |
| K951806 | Opgal Intraoperative Vascular Angiography System (Iva-2000) | Opgal Optronic Industries | LHQ | Class I | |
| K951805 | Piper, Model Number Uds-Piperb | Abbott Medical | FEN | Class II | |
| K951759 | Gsi 65 Computerized Audiometer | Grason-Stadler, Inc. | EWO | Class II | |
| K951716 | Ams 650 Mallerable Peniel Prosthesis | American Medical Systems, Inc. | FAE | Class II | |
| K951673 | Rod, Fixation, Intramedullary and Accessories | Acu Med, Inc. | HSB | Class II | |
| K951524 | Thoracentesis Catheter | Baxter Healthcare Corporation | JOL | Class II | |
| K951118 | 3M Maxi-Driver II Electric System | 3M Company | GEY | Class I | |
| K950711 | T-350 Therapeutic Cooling Machine | Thermotek, Inc. | ILO | Class II | |
| K946380 | Nezhat-Dorsey Reusable Aspiration-Vac Probes with and without Puncture Cannula (Hereinafter Referred to as Aspiration-V) | American Hydro-Surgical Instruments, Inc. | HET | Class II | |
| K946236 | Profix Conforming Plus Tibial Insert | Smith & Nephew Richards, Inc. | KWH | Class II | |
| K946189 | Introport(tm) Catheter Model #1000(Ict) | Lifequest Medical, Inc. | LJT | Class II | |
| K945628 | Clear Advantage II | Mentor | EXJ | Class I | |
| K943856 | Fixation Pins/wires | Acu Med, Inc. | HTY | Class II | |
| K943494 | Hsg Catheter Set for Hystersalpingography | Lyco Enterprises, Inc. | LKF | Class II | |
| K941612 | F-230 Porous Femoral Hip Stem (Cementless) | Implex Corp. | LPH | Class II | |
| K931417 | Sterile Equipment Covers | Custom Medical Products, Ltd. | MMP | Class II | |
| K952432 | Symbiosis Bipolar Forceps | Boston Scientific Corporation | GEI | Class II | |
| K952425 | Olympus Apolipoprotein A1 Immunoturbidimetric Reagent | OLYMPUS Corporation of the Americas | JHN | Class I | |
| K952367 | Cypress Medical Products Vinyl Examination Glove | Cypress Medical Products LLC | LYY | Class I | |
| K952261 | Hydrocurve 3 Toric, II, II 55% Toric, II Aphakic 55%, Soft Mate II, Custom Eyes 55% | Pilkington Barnes-Hind, Ltd. | LPL | Class II | |
| K952182 | Opticlone Cd3/cd8 Monoclonal Antibodies | IMMUNOTECH s.r.o. | GKZ | Class II | |
| K952161 | Bipolar Coagulation Instrument | Johnson & Johnson Professionals, Inc. | GEI | Class II | |
| K951993 | Ubi Magiwel Ferritin Quantitative | United Biotech | DBF | Class II | |
| K951736 | Lock-Up | Medline | FMI | Class II | |
| K951533 | Easi-Lav Pediatric / Adult Gastric Lavage Kit | Ballard Medical Products | KDH | Class II | |
| K943986 | Link Endo Model Revision Cup | Turnkey Intergration USA, Inc. | HRS | Class II | |
| K932352 | Orthopedic Bone Plate | Osteomed | HRS | Class II | |
| K932350 | Orthopedic Screw Fixation | Osteomed | HWC | Class II | |
| K952711 | Lori-a | Lori Medical Laboratories, Inc. | ESD | Class I | |
| K952704 | Philips Easyvision | Philips North America LLC | IZI | Class II | |
| K952549 | Richards Torp | Smith & Nephew Richards, Inc. | ETA | Class II | |
| K952505 | Insulin-Like Growth Factor I (Igf-I), Immunoradiometeric Assay (Irma) | Nichols Institute | CFL | Class I | |
| K952418 | V40 Zirconia Femoral Heads | Howmedica Corp. | LZO | Class II | |
| K952285 | Amerlite Fsh Assay | Johnson & Johnson Clinical Diagnostics, Inc. | CGJ | Class I | |
| K952081 | Karl Storz Catheters, Adaptors, Suction/irrigation Catheters, Tubing | Karl Storz Endoscopy-America, Inc. | EOQ | Class II | |
| K951644 | Acutek's Clearpassage | Acutek Adhesive Specialties, Inc. | LWF | Class I | |
| K951545 | Ogden Anchor for All Orthopaedic Soft Tissue Applications | American Medical Electronics, Inc. | HWC | Class II | |
| K951506 | Suction Catheter Kit, Sterile, Single-Use | Trinity Laboratories, Inc. | BSY | Class I | |
| K951493 | Ogden Anchor | American Medical Electronics, Inc. | HWC | Class II | |
| K951472 | Lmt Bone Anchor | Li Medical Technologies, Inc. | HWC | Class II | |
| K951434 | Opus Procainamide | Behring Diagnostics, Inc. | LAR | Class II | |
| K951233 | Lmt Bone Anchor | Li Medical Technologies, Inc. | HWC | Class II | |
| K951144 | Phoenix Plus & Base Nuclear Medicine Single Detector Systems | GE Healthcare | KPS | Class II | |
| K950816 | One Touch II Hospital Blood Glucose Monitoring System | Lifescan, Inc. | CGA | Class II | |
| K950489 | Graphic Controls Biotac Jr. ECG Electrode | Graphic Controls Corp. | DRX | Class II | |
| K950488 | Graphic Controls Biotac Eco Electrode | Graphic Controls Corp. | DRX | Class II | |
| K945985 | Pc Holter Scanning System Simplicity, Altair 8200, 8300, 8400 | Burdick Corp. | DQK | Class II | |
| K943806 | Harpoon Suture Anchors | Zimmer GmbH | HWC | Class II |