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 |
|---|---|---|---|---|---|
| K980062 | Monojectt Bluntip i.v. Access Cannula with Vial Access Pin Device | Davis & Geck, Inc. | FMI | Class II | |
| K974881 | Triage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin a | Biosite Incorporated | MCB | Class I | |
| K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | MAI | Class II | |
| K974798 | Sterichek(tm) Residual Peroxide Reagent Strps | Environmental Test Systems, Inc. | LIF | Class II | |
| K974788 | Cre(tm) Balloon Dilatation Catheter | Boston Scientific Corporation | KNQ | Class II | |
| K974611 | Micro-Strip for Amphetamine Metabolites | Microdiagnostics, Inc. | DKZ | Class II | |
| K970599 | Townley Pedicle Screw Plating System | Danek Medical, Inc. | MNI | Class II | |
| K980824 | A&d Ub-322 Watch Style Wrist Digital Blood Pressure Monitor | A and D Engineering, Inc. | DXN | Class II | |
| K980698 | Astra Tech Implants - Dental System | Astra Tech, Inc. | DZE | Class II | |
| K980565 | Ld2000 Series | General Scanning, Inc. | LMA | Class II | |
| K980561 | Dermium | Premier Laser Systems, Inc. | GEX | Class II | |
| K980523 | Irma Blood Analysis System with Optional Multi-Use Cartridge | Diametrics Medical, Inc. | CHL | Class II | |
| K980313 | Schwartz Electro-Optics, Inc. Clr 2940 Erbium Crystalase | Schwartz Electro-Optics, Inc. | GEX | Class II | |
| K980242 | Il Test Heparin | Instrumentation Laboratory Co. | KFF | Class II | |
| K980001 | Jenascan | Jenoptik Laser, Optik, Systeme GmbH | GEX | Class II | |
| K974793 | Elmed Esu 120 M/m Digital | Elmed, Inc. | GEI | Class II | |
| K974464 | Oratec Spinecath Intradiscal Catheter | Oratec Interventions, Inc. | GEI | Class II | |
| K974202 | Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus | Pulpdent Corporation | LBH | Class II | |
| K973839 | Disposable Esophageal Stethoscope | Biomerics | BZT | Class II | |
| K973532 | Stealth, Metered Dose Inhaler (Mdi) Spacer without Integral Actuator | Dhd Diemolding Healthcare Div. | CAF | Class II | |
| K970093 | Tyrosine 50-Hour Reagent Kit | Astoria-Pacific, Inc. | CDR | Class I | |
| K963794 | Punctureneedle | Ferguson Medical | KNW | Class II | |
| K962615 | Tumorlocalizer MRI | Ferguson Medical | MIG | Unclassified | |
| K980454 | Lysonix Aspiration Pump | Lysonix, Inc. | BTA | Class II | |
| K980377 | Fonix Fp35 Hearing Aid Analyzer | Frye Electronics, Inc. | ETW | Class II | |
| K980173 | Access Total Bhcg Reagents on the Access Immunoassay Analyzer; 33500, 33505 | Beckman Instruments, Inc. | JHI | Class II | |
| K980023 | Endopath and Proximate Linear Cutters | Ethicon Endo-Surgery Inc | GCJ | Class II | |
| K974908 | Synthes Sterile 2.7 Mm Reconstruction Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K974785 | Auto-Drive Bone Screw | Osteomed | HWC | Class II | |
| K974746 | M1765a ECG Manager | Hewlett-Packard Co. | DPS | Class II | |
| K974740 | Depuy Tri-Lock Hip Stem | Depuy, Inc. | LPH | Class II | |
| K974732 | Nidek Multi Color Laser Photocoagulator, Model Mc-7000 | Nidek, Inc. | GEX | Class II | |
| K974726 | Subdural Drainage Catheter Kit, Subdural Catheter | Elekta Implants, SA | JXG | Class II | |
| K974725 | Bioz.com System | Cardiodynamics International Corp. | DSB | Class II | |
| K974544 | Asu-1000 Diagnostic Ultrasound Transducer | Aloka Co., Ltd. | ITX | Class II | |
| K974186 | Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating | Orthofix SRL | JDW | Class II | |
| K973687 | Spinal Concepts, Inc., Bacfix Ti Spinal Fixation System | Spinal Concepts, Inc. | MNH | Class II | |
| K972225 | Ufr Fiberoptic Cable | Universal Fiberoptic Repair, Inc. | FST | Class II | |
| K972162 | Elecsys Ca 125 II | Boehringer Mannheim Corp. | LTK | Class II | |
| K963642 | Incl II Endoscope | Sofamor Danek USA,Inc. | GWG | Class II | |
| K980247 | Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum | Gynex Corp. | HDC | Class II | |
| K980241 | Netco Medical Data Transportation Service Software | Netco Communications Corp. | LMD | Class I | |
| K980213 | Di-2000 | Lumisys, Inc. | LMA | Class II | |
| K980118 | Kodak Digital Science Oncology Image Manager | Eastman Kodak Company | LLZ | Class II | |
| K974863 | Imix Digital Thorax System | Advanced Instrument Development, Inc. | KPR | Class II | |
| K974778 | Abbott Gemstar IV Infusion Pump | Abbott Medical | FRN | Class II | |
| K973364 | 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage Bag | Maersk Medical A/S | KNX | Class II | |
| K973129 | Denver Ascites Shunts, Denver Ascites Shunt Percutaneous Access Kits | Denver Biomaterials, Inc. | KPM | Class II | |
| K972981 | Shield Helico-G2 Elisa Kit | Shield Diagnostics, Ltd. | LYR | Class I | |
| K972873 | Immustrip Hama Igg | Immunomedics, Inc. | DAK | Class II |