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 |
|---|---|---|---|---|---|
| K013383 | Biohex One-Piece One Stage Dental Implant System | Biomedical Implant Technology, Inc. | DZE | Class II | |
| K013078 | Actalyke Mini Activated Clotting Time Test System, Model 5750/5752 | Helena Laboratories, Corp. | JBP | Class II | |
| K012745 | Triage Tox Drug Screen, Catalog #94000 | Biosite Incorporated | DKZ | Class II | |
| K012077 | Immulite Rubella Igm,lkrm1, Lkrm2, Immulite 2000 Rubella Igm, Model L2krm2, L2krm6 | Siemens Healthcare Diagnostics Inc. | LFX | Class II | |
| K012075 | Immulite Toxoplasma Igm, Model Lktm1 and Lktm2, Immulite 2000 Toxoplasma Igm, Model L2ktm2 and L2ktm6 | Siemens Healthcare Diagnostics Inc. | LGD | Class II | |
| K010577 | Bodygem, Model Hb211 | Healthetech, Inc. | BZL | Class II | |
| K010033 | Light Projector with Endoscopic Camera, 1 Ccd Camera Head Ntsc, 1 Ccd Camera Head Pal, Light Projector, Model 5551.107 | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K014049 | Epoca Codr Stem and Head | Globus Medical, Inc. | KWT | Class II | |
| K013529 | Point 4 Translucent Modified | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K013385 | Nexgen Complete Knee Solution Rotatng Hinge Knee | Zimmer GmbH | KRO | Class II | |
| K013243 | Coaptite Laryngeal Augmentation System 1Cc & O.5cc, Models 0008021-1, 0008022-1 | Bioform, Inc. | KHJ | Class II | |
| K014130 | Nlite System | Icn Photonics, Ltd. | GEX | Class II | |
| K014100 | Opus Spectrum (a Model of Opus 20), Model 2Nd | Opusdent, Ltd. | GEX | Class II | |
| K014083 | Haemonetics Cell Saver 5 Autologous Blood Recovery System | Haemonetics Corporation | CAC | Class II | |
| K014080 | Apex Adult Hollowe Fiber Oxygenator | Dideco S.p.A. | DTZ | Class II | |
| K014078 | On Site Gas Systems Portable Oxygen Generator System | On Site Gas Systems Inc. | CAW | Class II | |
| K013976 | Boehringer MRI Suction Regulatory | Boehringer Laboratories, LLC | KDP | Class II | |
| K013956 | Diamedix Is-Anti-B2 Glycoprotein I Screen | Diamedix Corp. | MSV | Class II | |
| K013775 | Twinfix Interfragmentary Compression Screw System | Stryker Leibinger | HRS | Class II | |
| K013757 | Roche Acetaminophen | Roche Diagnostics GmbH | LDP | Class II | |
| K013724 | Bicart | Gambro Renal Products | KPO | Class II | |
| K013718 | Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair | Gynecare, A Div. of Ethicon, Inc. | OTO | Class II | |
| K013695 | Microline Inc. Reusable Laparoscopic Clip Applier with Implantable Titanium Clips, Model M/l-10 | Microline Pentax, Inc. | GCJ | Class II | |
| K013671 | L-25 Absorbable Surigcal Suture | United States Surgical, A Division of Tyco Healthc | GAM | Class II | |
| K013648 | Viabahn Endoprosthesis | W. L. Gore & Associates, Inc. | JCT | Class II | |
| K013592 | Extremity Coil | GE Healthcare Coils | MOS | Class II | |
| K013589 | Chlorinated Powder Free Latex Medical Examination Gloves with Aloe Vera | Supermax Glove Manufacturing Sdn Bhd | LYY | Class I | |
| K013421 | Lifeguard Nasal CPAP Mask and Accessories | Lifeguard Medical Products, Inc. | BZD | Class II | |
| K013387 | Datex-Ohmeda S/5 Web Viewer | GE Healthcare | MSX | Class II | |
| K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | GEX | Class II | |
| K013365 | Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of Tattoos | Medical Bio Care Sweden AB | GEX | Class II | |
| K013062 | Biocheck Human Cardiac Troponin-I Immunoassay Test Kit | BioCheck Inc | MMI | Class II | |
| K011876 | Dolphin II Fluid Management System, Model Dol-2 | Circon Video | HIG | Class II | |
| K011855 | Wampole Hs-Crp Elisa | Carter-Wallace, Inc. | DCN | Class II | |
| K011842 | Sabre Compac | Sle Limited | GWJ | Class II | |
| K011238 | Roda (Real Time Oxygen Dynamics Analysis) Monitoring System | Metracor Technologies, Inc. | LZF | Class II | |
| K011190 | Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx Lp System) | Surx, Inc. | MUK | Class II | |
| K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | QSY | Unclassified | |
| K014191 | M2540 Diagnostic Ultrasound System, Model M2540 | Philips North America LLC | IYN | Class II | |
| K014084 | Nycocard Crp Control | Trinity Biotech (Primus Corporation dba Trinity Biotech) | DCK | Class II | |
| K014007 | Dynalink .018 Billary Self-Expanding Stent System | Boston Scientific Corporation | FGE | Class II | |
| K013523 | Cistem Fluid Transfer Device, Model 7S2012 and 7S2013 | Shire Biologics, Inc. | LHI | Class II | |
| K013384 | Sharghp A.v. Fistula Needle Set | Shargh Pharmaceutical Co., Inc. | FIE | Class II | |
| K013345 | Incare Intermittent Catheter | Hollister, Inc. | KOD | Class II | |
| K012275 | Pj.s Comfort Portable Electric Breast Pump | Limerick, Inc. | HGX | Class II | |
| K011537 | Dynamic Hollow Fiber Dialyzer Ds-Series, Model: Polysulfone 100 Hfs, Polysulfone 130 Hfs | Dynamic Technology Corp. | KDI | Class II | |
| K014037 | Sjm Seguin Annuloplasty Ring (Seguin Ring), Model Sarp-(Size) | Abbott Medical | KRH | Class II | |
| K013174 | Proges Folysil Silicone Foley Catheter, Straight Cylindrical Tip, Silicone Female Foley Catheter, Straight Cylindrical, | Porges Corp. | EZL | Class II | |
| K014182 | Tetrad Model Tc-C52-, -C84v-, -C95-, -Cla76-, -L74-Atp Transducers | Tetrad Corp. | ITX | Class II | |
| K013601 | Numed Mullins Pta Catheter | Numed Inc | DQY | Class II |