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 |
|---|---|---|---|---|---|
| K946177 | Valleylab Ns 2000 Bipolar Generator System | Medtronic, Inc. | GEI | Class II | |
| K945956 | Strato Medical Infuse-a-Cath Triple Lumen Silicone Catheter Systems | Strato Medical Corp. | LJS | Class II | |
| K945254 | Electrosurgical Cutting & Coagulation Device Accessories | Endotec, Inc. | GEI | Class II | |
| K944999 | Serum Bilirubin Control- Level 1, 2 and 3 | More Diagnostics Inc. | JJX | Class I | |
| K942688 | Nephro-Ureteral Stent | Uresil, LLC | LJE | Unclassified | |
| K942563 | Elite Biofeedback | Abbott Medical | HIR | Class II | |
| K941366 | Osteonics Omnifit Ad-Ha Hip Stem Series | Osteonics Corp. | MEH | Class II | |
| K935523 | Natural-Knee(r)/apollo(tm) Knee | Intermedics Orthopedics | JWH | Class II | |
| K952466 | Olympus Apolipoprotein B Immunoturbidimetric Reagent | OLYMPUS Corporation of the Americas | JHN | Class I | |
| K952263 | Programmable Two Memory, Single Band Behind the Ear Hearing Instrument | Siemens Hearing Instruments, Inc. | ESD | Class I | |
| K952228 | Sonar Cic Completely in-the-Canal Hearing Device | Resound Corp. | ESD | Class I | |
| K952085 | Dpd Defibrillator | Medical Research Laboratories, Inc. | LDD | Class II | |
| K952077 | Hemagen Ena Screen-6 Kit (Eia Method) | Hemagen Diagnostics, Inc. | LLL | Class II | |
| K952076 | Hemagen Ena Screening Kit (Eia Method) | Hemagen Diagnostics, Inc. | LLL | Class II | |
| K952060 | Qct-Bone Mineral Analysis Software or Oct-Bmd Option or Oct-5000 | Image Analysis, Inc. | KGI | Class II | |
| K951937 | Biopath Self-Tapping Dental Implant System (5Mm, 6Mm) | Bio Path | DZE | Class II | |
| K951804 | Karl Storz Subglottiscope, Neonate and Infant, Fiber Optic Light Carrier, Suction Tube | Karl Storz Endoscopy-America, Inc. | CCW | Class I | |
| K951352 | Dexon S, Dexon Plus, and Dexon II Polyglycolic Acid Suture | Davis & Geck, Inc. | GAM | Class II | |
| K951024 | Nature's Cradle | Infant Advantage, Inc. | FMS | Class II | |
| K950781 | Compact 7600 | GE Dec Medical Systems | JAA | Class II | |
| K946332 | Karl Storz Micro-Instrument for Cochlear Implantation | Karl Storz Endoscopy-America, Inc. | EQJ | Class I | |
| K946085 | Thin-Film Cardiac Gating Cable | General Electric Co. | LNH | Class II | |
| K945903 | Brainlab Mask System | Brainlab Med. Computersysteme GmbH | IYE | Class II | |
| K945594 | Deca Dermatome (Micromotor System) | Depuy Intl., Ltd. | GFD | Class I | |
| K945379 | Platinum Plus Guidewire with Hydrophilic Coating | Boston Scientific Corporation | DQX | Class II | |
| K944602 | Valleylab Force Fx | Medtronic, Inc. | GEI | Class II | |
| K943948 | Protective Shorts | Y. Daneshvar, M.D. | DXC | Class II | |
| K934913 | Heartrac ECG Monitoring System | Cardiac Telecom Corp. | QYW | Class II | |
| K932050 | Nh-2002 | New Horizon Health Care | QJQ | Class II | |
| K952193 | Osteotomes | Steri-Oss, Inc. | DZE | Class II | |
| K951783 | Bond-on 4 | Degussa AG | EJT | Class II | |
| K951781 | Pors on Plus | Degussa AG | EJT | Class II | |
| K951779 | Degulor M | Degussa AG | EJT | Class II | |
| K951677 | Rionet Hearing Aid Hm-02 | Authorized Hearing Systems, Inc. | ESD | Class I | |
| K951292 | Passport Foldable Lens Placement System | Chiron Vision Corp. | KYB | Class I | |
| K951125 | Lifeforce Clinical Hyperbaric Facility | Reimers Systems, Inc. | CBF | Class II | |
| K951098 | Hdc Vadd (Vascular Access Device) Tunneler | Hdc Corp. | LJS | Class II | |
| K951047 | Bacterial/viral Filter Product Numbers 5100Filt, 5100Thinm, 5100Hepa | Vital Signs, Inc. | CAH | Class II | |
| K951026 | Davol Arthro-Flo 3 | Davol Inc., Sub. C.R. Bard, Inc. | HRX | Class II | |
| K950993 | Butler G.u.m. Antibacterial Toothbrush | John O. Butler Co. | EFW | Class I | |
| K950987 | Strato/infusaid Tunneler | Strato/Infusaid, Inc. | LJS | Class II | |
| K950957 | Multiplace Hyperbaric Treatment Chamber System | Gulf Coast Hyperbarics, Inc. | CBF | Class II | |
| K950956 | Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute | Bio-Vascular, Inc. | GXQ | Class II | |
| K950622 | Mega Meditex Limited | Mega Meditex, Ltd. | LYY | Class I | |
| K950450 | Powder Free Latex Examination Gloves | Rampart Glove Co. | LYY | Class I | |
| K950340 | Ight and Eleven Gallon Sharps and Chemotherapy Containers | Bemis Mfg. Co. | MMK | Class II | |
| K950114 | Stotz Protege(tm) Microsurgical System | Storz Instrument Co. | HQC | Class II | |
| K945909 | Navarre N-Fuser(tm) Peripheral Infusion Catheter | Navarre Biomedical, Ltd. | KRA | Class II | |
| K945799 | Neurosign 100 Impedance Meter | Magstim Inc. | ETN | Class II | |
| K945674 | Mandibular Bone Distractor | Howmedica Corp. | MQN | Class II |