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 |
|---|---|---|---|---|---|
| K032265 | Cd Horizon Spinal System | Medtronic Sofamor Danek | KWQ | Class II | |
| K032228 | Lorenz 2.4 Self Drilling Screws | Biomet Microfixation | HWC | Class II | |
| K032001 | Poly Q (Garant L, Penta M, Penta H) | 3M Espe AG Dental Products | ELW | Class II | |
| K031923 | Ultrasite Valve | B.Braun Medical, Inc. | FPA | Class II | |
| K031636 | Cs100 Intra-Aortic Balloon Pump, Model 0998-00-3013-Xx | Datascope Corp. | DSP | Class II | |
| K031562 | Ramsoft Pacs, Model 3.0 | Ramsoft, Inc. | LLZ | Class II | |
| K031549 | Solid State Lamp [LED] Headlight | Welch Allyn Inc | FSR | Class II | |
| K031548 | LED Headlight | Welch Allyn Inc | FSR | Class II | |
| K030908 | Deroyal Surgical Drapes Backtable Cover | Deroyal | KKX | Class II | |
| K030055 | Mallory/head Total Hip System; Ha Mallory/head Total Hip System; Bi-Metric Femoral Components | Zimmer GmbH | LPH | Class II | |
| K024293 | Bowie-Dick Mini Pak, Model Bd 115 | Steritec Products, Inc. | JOJ | Class II | |
| K032339 | Cardiovations Portable Video System | Ethicon, Inc | GCJ | Class II | |
| K032264 | Modular Replacement System (Mrs) Humeral Stem | Howmedica Osteonics Corp | HSD | Class II | |
| K032244 | Gamma 3 Nail System | Howmedica Osteonics Corp | HSB | Class II | |
| K032224 | Biorci Screw | Smith & Nephew, Inc. | HWC | Class II | |
| K032215 | Vks/tc-Plus Revision Knee | Plus Orthopedics | JWH | Class II | |
| K032206 | Paramount Mini Stent and Delivery System Biliary Indication | Medtronic, Inc. | FGE | Class II | |
| K032197 | Twin Fix Ab 6.5 Mm Suture Anchor, Models 720209, 7210210, 7210211, 7210212 | Smith & Nephew, Inc. | MAI | Class II | |
| K032162 | Access Immunoassay System Toxo Igg Assay | Siemens Healthcare Diagnostics Inc. | LGD | Class II | |
| K032142 | Datacaptor | Capsule Technologie | MWI | Class II | |
| K032117 | Stryker Total Performance (Tps) System | Stryker Corp. | DZI | Class II | |
| K032097 | Depuy Ace Versanail Tibial Nail | Depuy Orthopaedics Inc. | HSB | Class II | |
| K032095 | Interpore Cross Cement Restrictor | Interpore Cross Intl. | JDK | Class II | |
| K032050 | Perivac Kit | Boston Scientific Corporation | DQX | Class II | |
| K032017 | Liquichek D-Dimer Control Level 1, 2 and 3 | Bio-Rad | GGN | Class II | |
| K032015 | Embryon Ultrasound Needle Guide | Rocket Medical | MQE | Class II | |
| K031900 | Handmaster | Ness-Neuromuscular Electrical Stimulation Systems | GZI | Class II | |
| K031789 | Eg-3830Ut, Video Ultrasound Gastroscope | Pentax Precision Instrument Corp. | ODG | Class II | |
| K031744 | Omnifit Hfx Hip Stem Series | Howmedica Osteonics Corp | JDI | Class II | |
| K031702 | Reflex Anterior Cervical Plate System | Howmedica Osteonics Corp | KWQ | Class II | |
| K031654 | Synthes Resorbable Cranial Clamp, (Modified) | Synthes (USA) Products LLC | GXR | Class II | |
| K031608 | Randox Liquid Protein Calibrator | Randox Laboratories, Limited | JIX | Class II | |
| K031428 | Synthes (USA) Large External Fixation Clamps-Mr Safe | Synthes (USA) Products LLC | LXT | Class II | |
| K030596 | Immunicon Cellsave Preservative Tube | Immunicon Corp. | JKA | Class II | |
| K030529 | Legend (Brand) Nitrile Powder-Free Patient Examination Glove | Jda (Tianjin) Plastic Rubber Co., Ltd. | LZA | Class I | |
| K030369 | Opus Spinal System | Howmedica Osteonics Corp | NKB | Class II | |
| K030302 | Hbs Headless Bone Screw | Schoening & Assoc., Inc. | HWC | Class II | |
| K030109 | Electrophysiology Catheter | Alliance Medical Corp. | NLH | Class II | |
| K024359 | Vista Scientific Barium Sulfate, Model 3001-1 | Vista Scientific, LLC | MYU | Class II | |
| K032035 | Synchron Lx Systems Complement C3 (C3) Reagent, Synchron Lx Systems Complement C4 (C4) Reagent, Synchron Lx Systems Cali | Siemens Healthcare Diagnostics Inc. | CZW | Class II | |
| K032014 | N Latex Igm | Siemens Healthcare Diagnostics Inc. | CFN | Class II | |
| K031992 | Echelon Micro Catheter, Model 105-5091 | Medtronic, Inc. | KRA | Class II | |
| K031924 | Vitros 5,1 Fs Chemistry System, Vitros Chemistry Products Dhdl Reagent Pack, Calibrator Kit 19, Fs Calibrator 1 | Ortho-Clinical Diagnostics, Inc. | JIT | Class II | |
| K031778 | Practicebuilder 1-2-3 | Erad Imagemedical Corp. | LLZ | Class II | |
| K031672 | Spinal Concepts, Inc. Infix System | Spinal Concepts, Inc. | MQP | Class II | |
| K031630 | Bifurcated Allergy Skin Testing Needle | Precision Medical Products | SCL | Class II | |
| K031586 | Correstore Patch System | Somanetics Corp. | DXZ | Class II | |
| K031544 | Heater Cooler Unit, Model Hcu 30 | Jostra AG | DWC | Class II | |
| K031432 | Klein Surgical Infiltration Pump, Model Kip-II | HK Surgical Inc | FRN | Class II | |
| K031349 | Otp 1.2 | Nucletron BV | MUJ | Class II |