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 |
|---|---|---|---|---|---|
| K945066 | Awesmosis | Applied Water Engineering, Inc. | FIP | Class II | |
| K955177 | Olympic Smart Scale | Olympic Medical Corp. | FRW | Class I | |
| K955127 | Hanyang Sunglasses | Hanyang Industries, Inc. | HQY | Class I | |
| K954846 | Olympic Smart Scale | Olympic Medical Corp. | FRW | Class I | |
| K954340 | Storz Microflow Phacoemulsification Needle | Storz | HQC | Class II | |
| K954140 | Masterscreen Ios | Erich Jaeger GmbH & Co. KG | BZG | Class II | |
| K953826 | Enzyme Linked Umminoabsorbent Assay, Rubella | Pyramid Biological Corp. | GOM | Class II | |
| K943678 | Electronic Flow Meter | Vitalograph, Inc. | BZH | Class II | |
| K955383 | Spyrocolloid Wound Dressing | Polymedica Industries, Inc. | MGP | Unclassified | |
| K955292 | Aeliteflo | Bisco, Inc. | EBF | Class II | |
| K955138 | Anti-Em/gp Stockings | Jobst Institute, Inc. | DWL | Class II | |
| K955100 | Carbamazepine Eia Test | Diagnostic Reagents, Inc. | KLT | Class II | |
| K955089 | Alpha-Dent Zinc Oxide Eugenol Temporary Cement | Wallace A. Erickson & Co. | EMA | Class II | |
| K955042 | Chromalex C-Reactive Protein Latex Test System | Shared Systems, Inc. | DCN | Class II | |
| K955001 | Evershears Scissors, Bilap Probes, Bicoag Forceps | Everest Medical Corp. | GEI | Class II | |
| K954993 | Quix Rapid Pregnancy Strip Test | Guardian Scientific, Corp. | JHI | Class II | |
| K954809 | Unipolar Temporary Myocardial Pacing Wire Model 6494 | Medtronic, Inc. | LDF | Class II | |
| K954799 | Ontraj Testcup Collection/urinalysis Panel | Roche Diagnostic Systems, Inc. | DIF | Class I | |
| K954697 | Ciba Corning Acs Estradiol-6 Assay | Ciba Corning Diagnostics Corp. | CHP | Class I | |
| K954630 | Depuy Titanium Cross Pin Fixation System | Depuy, Inc. | JDW | Class II | |
| K954554 | Alta Tibial/humeral Rod | Howmedica Corp. | HSB | Class II | |
| K954300 | Argyle Neo-Sert Hydrophilic Polyurethane Umbilical Vessel Catheter Insertion Tray | Sherwood Medical Co. | FOS | Class II | |
| K953731 | Pancretec Provider Apm Infusion Pump (Modification) | Abbott Medical | FRN | Class II | |
| K953120 | Vital Signs Heparin Vascular Access Flush Device | Vital Signs, Inc. | FOZ | Class II | |
| K952860 | The Niner Nitinol Guidewire | Microvena Corp. | DQX | Class II | |
| K952766 | Rayhack Osteotomy System (Modification) | Creative Medical Designs, Inc. | HRS | Class II | |
| K952645 | Vital Signs Saline Vascular Access Flush Device | Vital Signs, Inc. | FOZ | Class II | |
| K952298 | Spinal Pedicle Screw, Fixation, Appliance | J.B.S., S.A. | MNH | Class II | |
| K950565 | Deroyal Surgical Instrument Drape | DeRoyal Industries, Inc. | KKX | Class II | |
| K935585 | Apr Acetabular Inserts Ioi Bipolar | Intermedics Orthopedics | JDI | Class II | |
| K954319 | Amoxicillin/clavulanic Acid 2/1 | Ab Biodisk | JWY | Class II | |
| K953642 | Ap-18 | Jeneric/Pentron, Inc. | JEH | Class II | |
| K952780 | Urinary Gel Drainage System | P.A.M., Inc. | EYZ | Class I | |
| K950473 | Disposable ECG Monitoring Electrode | Nikomed U.S.A., Inc. | DRX | Class II | |
| K955946 | Acetal Dental/preformed Clasp | Pressing di Monticelli Rag. Stefano | EHP | Class I | |
| K955429 | Prostyle Intra | Planmeca Oy | EHD | Class II | |
| K955395 | Dar-2400-15B/30b | Shimadzu Medical Systems | IZI | Class II | |
| K955232 | Nt Series Digital Image Manager | Camtronics, Ltd. | LMB | Class I | |
| K955154 | Cal 1 & Cal 2 Solution, Flush Solution Kit | Alko Diagnostic Corp. | JIX | Class II | |
| K955118 | Degubond X-Lite Plus | Degussa AG | EJT | Class II | |
| K955070 | Optibond; Optiaid, Optirep, Optishine, Optichroma, Optifarb & Optiwak | Optimal Dental (USA) | EIH | Class II | |
| K955068 | Optibond 2A Precoat | Sybron Dental Specialties, Inc. | EMA | Class II | |
| K954971 | Acetal Dental/preformed Clasp | B & H Technical Services, Ltd. | EHP | Class I | |
| K954901 | Bionike A/q Pregnancy Test | Bionike Laboratories, Inc. | JHI | Class II | |
| K954841 | Model D-285N Administration Set | Patient Solutions, Inc. | FPA | Class II | |
| K954535 | Elastyren Hypoallergenic Surgical Gloves | Eci Medical Technologies, Inc. | KGO | Class I | |
| K954533 | Elastyren Hypoallergenic Patient Examination Gloves | Eci Medical Technologies, Inc. | LZA | Class I | |
| K954417 | A-B Acetabular Component | Zimmer GmbH | LPH | Class II | |
| K954381 | Shanghai Posedon Plastic Products Vinyl Exam Gloves | Shanghai Poseidon Plastic Products Co., Ltd. | LYZ | Class I | |
| K954365 | Powder Free Latex Examination Gloves | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I |