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 |
|---|---|---|---|---|---|
| K912321 | Module: Nova Nucleus Tmg Module Fluid Pack | Nova Biomedical Corporation | JGJ | Class I | |
| K912154 | Qualitone Model 48 C-Wr-Behind the Ear | Qualitone | ESD | Class I | |
| K912153 | Quiltone Model 48 Pp-Agc-I-D-Behind the Ear | Qualitone | ESD | Class I | |
| K912112 | Pf-400,Gf-300,If-200,Pg400,pg400c,and Ed-480 | Tomey Corporation USA | LQJ | Class II | |
| K911842 | 3M Luting Cement, Paste a and B | 3M Company | EMA | Class II | |
| K911660 | Intrasite Hydrocolloid Wound Dressing | Smith & Nephew United, Inc. | MGP | Unclassified | |
| K911510 | Magna Surgical Packs | Dms Miami, Inc. | KKX | Class II | |
| K911509 | Magna Obstetrical Packs | Dms Miami, Inc. | KKX | Class II | |
| K911508 | Magna Surgeons Gowns | Dms Miami, Inc. | FYA | Class II | |
| K911439 | Non-Mydriatic Retinal Camera, Cr-45Uaf | Canon Medical Components U.S.A., Inc. | HKI | Class II | |
| K911385 | Coulter(r) Mh010 | Coulter Electronics, Inc. | GKZ | Class II | |
| K911345 | Hsv in Situ DNA Probe Hybridization Test Kit | Ortho-Clinical Diagnostics, Inc. | GQN | Class II | |
| K911280 | Shimadzu X-Ray High-Voltage Generator Xud150b | Shimadzu Medical Systems | IZO | Class I | |
| K911205 | Arthroscopy Instrument Cannula | Davol, Inc. | HRX | Class II | |
| K911200 | Si-1200 / Ilus | Siemens Ultrasound, Inc. | IYO | Class II | |
| K911078 | Multispect 3 Triple Detector Camera System | Siemens Gammasonics, Inc. | KPS | Class II | |
| K911052 | Nexus(tm) Femoral Hip Stem | Dow Corning Wright | JDI | Class II | |
| K910887 | Qm300 Control G Pack | Kallestad Diag, A Div. of Erbamont, Inc. | GTQ | Class I | |
| K910886 | Qm300 Antistreptolysin O (Aso) Antigen Pack | Kallestad Diag, A Div. of Erbamont, Inc. | GTQ | Class I | |
| K910885 | Qm300 Calibrator G Pack | Kallestad Diag, A Div. of Erbamont, Inc. | GTQ | Class I | |
| K910435 | Life Oxygenpac 6/12 Lpm | Life Corp. | BTL | Class II | |
| K910434 | Life Oxygenpac for Trained Medical Personnel | Life Corp. | BTL | Class II | |
| K905754 | Capnomac Ultima Anesthesia Monitor | Datex Division Instrumentarium Corp. | CBS | Class II | |
| K905737 | Centauri/pegasus | Pfizer Laser Systems | GEX | Class II | |
| K905306 | Mumps Complement-Fixation (C.f.) Antigen | Virion (U.S.), Inc. | GRC | Class I | |
| K905298 | Titan Total Hip Device | Dr. Jean-Marc Guichet | JDI | Class II | |
| K911765 | Hand Carried Stretcher | L.E. Phillips Career Development Center, Inc. | FPP | Class I | |
| K911136 | B-D Safety-Lok(tm) i.v. Needles | BD Becton Dickinson Vacutainer Systems Preanalytic | FPA | Class II | |
| K910836 | Lima Collared Cl Stem | Lima Intl. Corp. | JDI | Class II | |
| K903984 | Cw Doppler/4.5 Mhz | Diasonics, Inc. | ITX | Class II | |
| K911984 | Anemia I, II | Ciba Corning Diagnostics Corp. | JJY | Class I | |
| K911699 | Sti Tissue Manipulator | Surgical Technologies, Inc. | HIN | Class II | |
| K911612 | Nucletron Planning System | Nucletron-Oldelft Corp. | IYE | Class II | |
| K911268 | Surgical Rubber Gloves | Pacificlink Export | KGO | Class I | |
| K910928 | Rubber Latex Surgeons Gloves | Regent Hospital Products | KGO | Class I | |
| K910352 | Biopro Metal Backed Cemented Acetabular Cup | Biopro, Inc. | JDI | Class II | |
| K905794 | Pall 3N1 Filter | Pall Biomedical Products Co. | FPB | Class II | |
| K905774 | Thackray Titanium Mini-Plating System | Depuy, Inc. | HRS | Class II | |
| K905234 | Txp Transporter Family and Related Accessories | Percussionaire Corp. | CBK | Class II | |
| K911610 | Elisa Combi-Kit Human Igg Subclasses | Janssen Research Foundation | DEW | Class II | |
| K905810 | Noiles(tm) Total Knee Prosthesis, Modification | Joint Medical Products Corp. | JWH | Class II | |
| K904573 | Pentax Ultrasound Endoscope, Model Fg-32Ua | Pentax Precision Instrument Corp. | ODG | Class II | |
| K912239 | Vzvscan(tm) Latex Aggutination Test | BD Becton Dickinson Vacutainer Systems Preanalytic | GQW | Class II | |
| K912023 | Laserscope Disposable Laparostat W/irrig & Aspir | Laserscope | GCJ | Class II | |
| K911885 | Dade(r) Protein C Abnormal Contral | Baxter Healthcare Corporation | GGC | Class II | |
| K911817 | Endoscopic Clip Applier | Surgitech C/O Collier, Shannon, Rill & Scott | GCJ | Class II | |
| K911791 | Cdd-Pca(tm) Model 5800R Ambulatory Infusion Pump | Pharmacia Deltec, Inc. | MEA | Class II | |
| K911639 | Opti-Plast 5F Pta Catheters Oven Curing Procedure | Vas-Cath, Inc. | LIT | Class II | |
| K911607 | Gesco Umbili-Cath | Gesco Intl., Inc. | FOS | Class II | |
| K911365 | Electrocautery Cable, Bovie(tm)/banana Plugs | Northgate Technologies Inc. | GEI | Class II |