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 |
|---|---|---|---|---|---|
| K961349 | Injection Gold Probe | Boston Scientific Corporation | KNS | Class II | |
| K961327 | Bec Needleless Injection Site | Biological & Environmental Control Laboratories | FPA | Class II | |
| K961280 | Scimed 6-10 F Triguide Guide Catheters 6F,7f,8f,9f & 10F | Scimed Life Systems, Inc. | DQY | Class II | |
| K961273 | AED Calibrators | Diagnostic Reagents, Inc. | DKB | Class II | |
| K961256 | Synchron Systems Valproic Acid (Vpa) Reagent | Beckman Instruments, Inc. | LEG | Class II | |
| K961196 | Ektachem Clinical Chemistry Urea Nitrogen/urea (Bun/urea) | Johnson & Johnson Clinical Diagnostics, Inc. | CDN | Class II | |
| K961195 | Chem-Chex Stat | Streck Laboratories, Inc. | JJY | Class I | |
| K961015 | Scimed Choice/ptca Guide Wire/plus Ptca Guide Wire/exchange Ptca Guide Wire | Scimed Life Systems, Inc. | DQX | Class II | |
| K960969 | Galva 5-T | Zimmer Elektromedizin GmbH | GZJ | Class II | |
| K960713 | 8 Fr.-40Cc Arrow Flex Intra-Aortic Balloon Catheter with Blue Flex Tip, Product Number Iab-04840(Used with a 9Fr.sheath) | Arrow Intl., Inc. | DSP | Class II | |
| K960277 | Protective Latex Powdered Gloves | Highactive Sdn. Bhd. | LYY | Class I | |
| K960058 | Oxitemp, 3301T Sa | Bci Intl., Inc. | DQA | Class II | |
| K955689 | Rns Sterile, Disposable Digital Angiographic Tray | Contour Fabricators of Florida, Inc. | DWS | Class I | |
| K955585 | V2 Injection Site | B.Braun Medical, Inc. | FPA | Class II | |
| K955533 | Diastat Vascular Access Graft | W. L. Gore & Associates, Inc. | DYF | Class II | |
| K955356 | Active Ultra-Sensitive Unconjugated Estriol | Diagnostic Systems Laboratories, Inc. | CGI | Class I | |
| K954980 | Pagewriter 200, 200I Cardiograph & Interpretive Cardio | Hewlett-Packard Co. | LOS | ||
| K954457 | Medi-Tech Eddy Intravascular Infusion Catheter | Medi-Tech, Inc. | KRA | Class II | |
| K961670 | Clarity | Seig Technologies, Inc. | ESD | Class I | |
| K961178 | Karl Storz Intubation Fiberscope | Karl Storz Endoscopy-America, Inc. | EOQ | Class II | |
| K960867 | Frequency Doubled Nd:yag Photocoagulator(viridis) Frequency Doubled Nd:yag Photocoagulator(evergreen 532) | B.V. Intl. S.A. | GEX | Class II | |
| K960787 | Tur,arthroscopic,cystoscopy Irrigation Sets | Baxter Healthcare Corporation | LJH | Class II | |
| K960768 | Laser Fiber Delivery/cleaning Catheter | Cook Incorporated | GEX | Class II | |
| K960639 | Abutment Selection Kit | Nobelpharma USA, Inc. | DZE | Class II | |
| K955659 | Drugbox | C.F. Electronics, Inc. | LGZ | Class II | |
| K955583 | Vifs | Konica Medical Corp. | JAK | Class II | |
| K955412 | A.s.d. Safety Trocar | American Surgical Devices | HET | Class II | |
| K955380 | Ibc Quick Cell Component (1/2, 3/8, 1/4) | International Biophysics Corp. | DRY | Class II | |
| K955379 | Ibc Gas Cell Components (1/2, 3/8, 1/4) | International Biophysics Corp. | DRY | Class II | |
| K954325 | Neolon Neoprene Surgical Gloves | Maxxim Medical | KGO | Class I | |
| K954318 | Abbott Axsym Rubella Igm Antibody Assay | Abbott Medical | LFX | Class II | |
| K953083 | Hospital Laundry Services Surgical Packs | Hospital Laundry Services | LRO | Class II | |
| K951877 | Automated Analysis Assay for Bilirubin in Urine | Chimera Research & Chemical, Inc. | KQO | Class I | |
| K950712 | Portable Endoscopy System | Laser-Optik-Systeme GmbH & Co. KG | GCM | Class II | |
| K945105 | Poly/platinum Wire Piston | Micromed Development Corp. | ETB | Class II | |
| K944867 | Toxostat | Bio-Whittaker, Inc., A Cambrex Co. | LGD | Class II | |
| K961603 | Sun Clip | Intromark, Inc. | HQY | Class I | |
| K961523 | Tiny Toon Sunglasses & Cabbage Patch Kids Sunglasses | Dorda Toys | HQY | Class I | |
| K961513 | Procath Locking Peel-Away Introducer/peel-Away Introducer Set | Abbott Medical | DYB | Class II | |
| K960735 | Everglory Sunglasses | Everglory Creations, Inc. | HQY | Class I | |
| K960677 | Kangaroo Jejunal Feeding System | Sherwood Medical Co. | KNT | Class II | |
| K960648 | Phem-Chek | Femtek,Llc. | LNW | Class I | |
| K960622 | I-Scan | Ophthalmic Technologies, Inc. | IYO | Class II | |
| K960592 | Electrolyte Standards | Phoenix Diagnostics, Inc. | JJR | Class I | |
| K953116 | White Iris Leukocyte Differential Analyzer | Intl. Remote Imaging Systems | GKZ | Class II | |
| K951100 | Ortho-Mune Ok-Combo Cd3-Fitc/cd19-Pe (Okt3/okb19a Monolclonal Antibody (Murine) | Ortho Diagnostic Systems, Inc. | GKZ | Class II | |
| K950989 | Cardiosmart | Hellige GmbH | DPS | Class II | |
| K950625 | Ortho-Mune Ok-Combo Cd40fitc/cd8-Pe (Okt4a/okt8) Monoclonal Antibody (Murine) | Ortho Diagnostic Systems, Inc. | GKZ | Class II | |
| K950568 | Ortho-Mune Ok-Combo Cd3-Fitc/cd4-Pe (Okt2/okt4a) Monoclonal Antibody (Murine) | Ortho Diagnostic Systems, Inc. | GKZ | Class II | |
| K961683 | Jj Skinner Carekits Minor Surgical Procedure Tray | J.J. Skinner, Inc. | LRO | Class II |