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 |
|---|---|---|---|---|---|
| K970887 | Blood Flow Analyzer | Paradigm Medical Industries, Inc. | HKY | Class II | |
| K970083 | Dynabite Hot Gi Biopsy Forceps | Portlyn Corp. | KGE | Class II | |
| K965042 | Microdl Diarycard Spirometer | Micro Direct, Inc. | BZG | Class II | |
| K965041 | Ohmeda Apac (Advanced Portable Anesthesia Care) System | GE Healthcare | BSZ | Class II | |
| K964818 | Orion Series Surgical Laser System (Q-Switched Nd:yag Configuration) | Laserscope | GEX | Class II | |
| K963920 | 8 Fr.-30Cc Narrowflex Intra-Aortic Balloon Catheter, | Arrow Intl., Inc. | DSP | Class II | |
| K962312 | Key Chain Emergency Airway | Ffrench Pocket Emergency Airway, Inc. | BWC | Class II | |
| K972004 | Ise Reagents for Olympus Au 800/Au5200 Chemistry Systems | Alko Diagnostic Corp. | CGZ | Class II | |
| K971952 | Lyphochek Hypertension Markers Control (Cat. No. 600) | Bio-Rad | JJY | Class I | |
| K971902 | Roche Unimate Hdl Direct Reagent, Roche Calibrator Hdl Direct | Roche Diagnostic Systems, Inc. | LBS | Class I | |
| K971823 | Active Testosterone Eia (Dsl-10-4000) | Diagnostic Systems Laboratories, Inc. | CDZ | Class I | |
| K971779 | Total Triiodothyronine(t3) Microplate Eia | Monobind, Inc. | CDP | Class II | |
| K971709 | Total Throxine Microplate Eia(225-300) | Monobind, Inc. | KLI | Class II | |
| K971467 | Synchron Cx Systems Glucose Reagent (Glu) | Carolina Liquid Chemistries | CFR | Class II | |
| K971405 | Speciality Urine 1,2 | Chiron Diagnostics Corp. | JJY | Class I | |
| K971276 | Glucometer Encore Qa+ Blood Glucose Meter | Bayer Corp. | CFR | Class II | |
| K971247 | Snt Disposable Biopsy Needle | Surgical Navigation Technologies, Inc. | HAW | Class II | |
| K971190 | N-Geneous Hdl Cholesterol Kit/cholesterol Calibrator | Genzyme Corporation | LBS | Class I | |
| K971162 | Liquid N-Geneous Hdl Cholesterol Kit/calibrator | Genzyme Corporation | LBS | Class I | |
| K971111 | Tri-Tech Inc., Evacuated Blood Collection Tube, Gray Stopper | Tri-Tech, Inc. | JKA | Class II | |
| K971053 | Rockwell Medical Supply,llc. Bicarbonate Solution Concentrates for Bicarbonate Dialysis | International Medical Products, Inc. | KPO | Class II | |
| K970991 | Datex Engstom Manual Resuscitator | Promedic, Inc. | BTM | Class II | |
| K970150 | Mycoplasma Igg Elisa Test System | Zeus Scientific LLC | LJZ | Class I | |
| K970131 | Orthosonics Duo-Son Ultrasound Diathermy Device | C.L. Mcintosh & Assoc., Inc. | IMI | Class II | |
| K965044 | Gyrex 2T Prestige Model No. 100-6321-0107 and Gyrex Privilege Model No. 100-6326-0102 | Elscint, Inc. | LNH | Class II | |
| K964724 | Powder-Free Latex Examination Gloves | Pwa Industries Sdn. Bhd. | LYY | Class I | |
| K964368 | Elecsys Cea Assay | Boehringer Mannheim Corp. | JIT | Class II | |
| K964295 | N-Assay Tia Transferrin Test Kit | Crestat Diagnostics, Inc. | DDG | Class II | |
| K964264 | High Range Peroxide Test Strip | Integrated Biomedical Technology, Inc. | FKP | Class II | |
| K961634 | Nil - Powder-Free Latex Examination Gloves | Hl Rubber Products Sdn Bhd | LYY | Class I | |
| K971875 | Optim-Eyes 450 | Taylor/Fox Enterprises, LLC | HQY | Class I | |
| K971805 | Electrosurgical Tip Cleaner, Tip Cleaning Pad, Lectrobrasive Tip Cleaner, Electrosurgical Tip Cleaner, Electrode Tip Cle | Apyx Medical Corporation | GEI | Class II | |
| K971707 | Sunglasses (Non-Prescription) | Niko Sunglasses Corp. | HQY | Class I | |
| K971399 | Auris Ae, Auris Tl, Auris Hs, Auris Ac, Auris Mm, Auris Coe, Auris Cic | General Hearing Instruments, Inc. | ESD | Class I | |
| K971274 | C.a.t.s Continuous Autotransfusion System, At1 Autotransfusion Set, Psq Set | Fresenius AG | CAC | Class II | |
| K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | HRX | Class II | |
| K971230 | Sherwood Medical Company , Kangaroo, Entristar, Percutaneous Gastrostomy Kit | Innerdyne, Inc. | KNT | Class II | |
| K971186 | Amo Diplomax/opsys Console | Allergan | HQC | Class II | |
| K971158 | Dualine 400 Cic | Bernafon-Maico, Inc. | ESD | Class I | |
| K971115 | Ge Medical-Needle Guide for Sv, Tr Andatf, Acuson-Needle Guide | Protek Medical Products, Inc. | ITX | Class II | |
| K971087 | Sunglasses (Frame,cellulose Propinate, Lens, Acrylic) | W.J. Byrnes & Co. of los Angeles, Inc. | HQY | Class I | |
| K971074 | Therapax Sxt 150 | Pantak, Inc. | JAD | Class II | |
| K971054 | Osteo CT for the Somatom Ar Family and Plus 4 CT Systems | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K971001 | Autimo | Medizintechnik, GmbH | IXI | Class II | |
| K970983 | Peritoneal/cardiac Catheter | Integra Neurocare, LLC | JXG | Class II | |
| K970970 | Cardiomatch | Focus Medical, LLC. | KPS | Class II | |
| K970964 | Maestro Digital Image and Patient Record Storage System | International Imaging Electronics | LLZ | Class II | |
| K970959 | Instant Flow Vavle (Flowmeter, Pole, Rail, Wall Mount) | Instrumentation Industries, Incorporated | BTM | Class II | |
| K970785 | Sims Hyperinflation Bag System | Sims | NHK | Class II | |
| K970592 | N/a | North American Technical Services Corp. | ILY | Class II |