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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K871445 | Controlchek(tm) | Petra Biomedical Products, Inc. | JTO | Class I | |
| K871360 | 10F & 11.5F Mahurkar Dual Lumen Catheters, Useable | Quinton, Inc. | MPB | Class II | |
| K871144 | Tangent System(tm) Ana Profile Test Kit | Vitrotec Laboratories, Inc. | DHN | Class II | |
| K870958 | Titan Gel Multi-Slot Sp-17 Kit Cat. No. 3091 | Helena Laboratories, Corp. | CEF | Class I | |
| K870946 | Monabrite Chlamydia Trachomatis Dir. Specimen Test | Serono Diagnostics, Inc. | LJP | Class I | |
| K870629 | Calcium Test | Sclavo, Inc. | CIC | Class II | |
| K870518 | Surgitek Physician Dispen. Patient Self-Inject Kit | Surgitek | FMF | Class II | |
| K870201 | Dispens-O-Disc Broth Elution Disks Metron. 80 Mcg | Difco Laboratories, Inc. | JTN | Class II | |
| K870175 | Broth Elution Disks Clindamycin 10Mcg | Difco Laboratories, Inc. | JTN | Class II | |
| K864842 | Chlamydiazyme Diagnostic Kit | Abbott Medical | LJC | Class I | |
| K864128 | Chlamydia-Check(tm) Direct & Culture Confir. Kit | Diagnostic Technology, Inc. | LJP | Class I | |
| K871372 | Cb-7 Electronic Epilator | R. A. Fischer Co. Corp. | KCW | Class I | |
| K871331 | Ventrescreen Cat/dog Allergy Test Kit Enzyme Immu. | Ventrex Laboratories, Inc. | DHB | Class II | |
| K871314 | Cryosurgical Probe | Western Medical Research | GEH | Class II | |
| K870854 | Bacto(r) Strep Group Kit | Difco Laboratories, Inc. | GTZ | Class I | |
| K870792 | Thorastat Atr-Xxxx | Gish Biomedical, Inc. | DTP | Class II | |
| K870753 | Toxoplasma Igm Microassay | Diamedix Corp. | LGD | Class II | |
| K870210 | Clearview Cw-10 | Clearview Instruments, Inc. | GKR | Class II | |
| K870067 | Multicath - Code#s 8.1207.Oo/8.1208.00/8.1205.20 | Vygon Corp. | DQY | Class II | |
| K864643 | Glycoscreen Glycosylated Hemoglobin Assay Kit | Pacific Hemostasis | LCP | Class II | |
| K871408 | Blood Vessel Connector | Quali-Med, Inc. | |||
| K871326 | Drop Mate | Mtr Enterprises, Ltd. | |||
| K871299 | Sdi Total Hip System | Orthomet, Inc. | JDI | Class II | |
| K871285 | Knife, Ophthalmic | Trueline Instruments, Inc. | HNN | Class I | |
| K871250 | Intra-Articulated Arthro Power System | Richard Wolf Medical Instruments Corp. | KIT | Class I | |
| K871099 | Schirmer Nylon Suture Laser Lens | Ocular Instruments, Inc. | LQJ | Class II | |
| K870909 | Pacemaker Function Analyzer | Paceart, Inc. | KRE | Class II | |
| K870783 | Bpa Cardiovascular Pressure Amplifier | Fisher Imaging Corp. | DRQ | Class II | |
| K870542 | Vascath Vascular Catheter Placement Kit | Titan Medical, Inc. | DYB | Class II | |
| K870325 | #014160-Tab Tubing Rotator Adaptor | Clinical Connections, Inc. | DTL | Class II | |
| K870075 | Central Venous Catheter | BD Becton Dickinson Vacutainer Systems Preanalytic | DQY | Class II | |
| K864936 | 'Exmoor' Das Gupta Laryngeal Keel | Exmoor Plastics Limited | FWN | Class II | |
| K870905 | Sure Drop | Sheldon Eyedrop Support, Inc. | |||
| K871414 | Emds Tibc Pretreatment Set Item No. 67612/93 | Em Diagnostic Systems, Inc. | JMO | Class I | |
| K871237 | Sun Capsule I & II Suntanning Booth | Sun Capsule, Inc. | FTC | Class II | |
| K871176 | Pace 10 Non-Invasive External Pacemaker | Medac, Inc. | DRO | Class II | |
| K871138 | Foundations Plus Abdominal Band 1100 | Foundations Plus, Inc. | |||
| K871043 | (I) Lv and (II) Hv Series Cannula | Celebration Medical Products, Inc. | GEA | Class I | |
| K870917 | Protein S Control Plasma | American Bioproducts Co. | GGP | Class II | |
| K870771 | Pt Heparin Adsorbent | Probe-Tek, Inc. | JPA | Class II | |
| K870770 | Timleine(tm) Venipuncture System | Ipax, Inc. | KMK | Class I | |
| K870582 | Lifeport(r) 7 Inch Continuous Infusion W/y-Site | Strato Medical Corp. | FPA | Class II | |
| K870581 | Lifeport(r) 7 Inch Continuous Infusion Set | Strato Medical Corp. | FPA | Class II | |
| K870538 | Model 192 Printer | Advanced Medical Products, Inc. | DSF | Class I | |
| K870537 | Model Micro St Ambulatory ECG Monitor | Advanced Medical Products, Inc. | DSH | Class II | |
| K870147 | Carerite & Cost Rite Nylon Sterilization Film | Cost Rite Health Products, Inc. | FRG | Class II | |
| K861687 | Biojector Syringe System | Bioject, Inc. | KZE | Class II | |
| K871417 | Colorimetric Uric Acid Reagent Set | Biochemical Trade, Inc. | KNK | Class I | |
| K871415 | Microplate Luminometer Ml 1000 (No. 012-101-000) | Dynatech Laboratories, Inc. | JJQ | Class I | |
| K871352 | Pentavalent Antiserum to Human Immunoglobulins | Helena Laboratories, Corp. | DEW | Class II |