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 |
|---|---|---|---|---|---|
| K902542 | Philips Integris C2000 System | Philips North America LLC | IZI | Class II | |
| K902381 | Penlon Breathing System Pressure Monitor | Penlon, Ltd. | CAP | Class II | |
| K902370 | Modified Prostatic Urethroplasty Balloon Catheter | Boston Scientific Corporation | FAH | Class II | |
| K902309 | Parker Micropump Model 2100 | Chathamborough Research Group, Inc. | FRN | Class II | |
| K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | GEI | Class II | |
| K902297 | Busse Bac/shield | Busse Hospital Disposables | BSY | Class I | |
| K902276 | Respironics BIPAP Pressure Alarm (BIPAP P.a.) | Respironics, Inc. | CAP | Class II | |
| K902166 | Winged Infusion Set | Therex Corp. | FPA | Class II | |
| K901952 | Mag Reson Diag Dev Access Spec Purp Rec Only Coil | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K901920 | Prime Care Neonatal/pediatric Tracheostomy Tube | Primecare, Inc. | BTO | Class II | |
| K901589 | Rts Technology Iridium 192 Sources | Rts Technology, Inc. | JAQ | Class II | |
| K901312 | Perneczky Aneurysm Clip | Von Zeppelin GmbH | HCH | Class II | |
| K900428 | Anesthesia Breathing Circuits | Med-Tek Corp. | CAI | Class I | |
| K896497 | Percor Stat-Dl 8.5 Fr Intra-Aortic Balloon | Datascope Corp. | DSP | Class II | |
| K896224 | Cobas Ready Calcium Reagent | Roche Diagnostic Systems, Inc. | CIC | Class II | |
| K902744 | Degufill (Tm) Bond | Degussa AG | KLE | Class II | |
| K902497 | Scd Therapeutic Stocking System | Kendall Healthcare Products Co. Div.Of Tyco Health | DWL | Class II | |
| K902272 | O. B. Pack II | Customed, Inc | HHD | Class I | |
| K902271 | O. B. Pack I | Customed, Inc | HHD | Class I | |
| K901806 | Suction Ora-Swab(r) Brush Kit | Sage Products LLC | EIA | Class I | |
| K901725 | Add'l Transducer for Use W/the Combison 310A | Kretztechnik AG | ITX | Class II | |
| K901456 | Orthosorb(r) Absorbable Pin | Johnson & Johnson International | OVZ | Class II | |
| K900994 | Antegrade/retrograde Y W/integral Selector Swit. | Dlp, Inc. | DTL | Class II | |
| K900056 | Catheter with Guidewire Assembly Device | Abbott Medical | FOZ | Class II | |
| K903429 | Lido Linea | Loredan Biomedical, Inc. | IKK | Class II | |
| K903360 | Bair Hugger(r) Patient Warming System-Modification | Augustine Medical, Inc. | DWJ | Class II | |
| K903314 | Anti-Sci-70 Antibody Test | Immco Diagnostics, Inc. | LLL | Class II | |
| K903021 | Negative Pressure Arterial Line Cat. No: 03-9630 | National Medical Care, Medical Products Div., Inc. | FJK | Class II | |
| K902970 | Precision Medical Disposable Humidifier | Precision Medical, Inc. | BTT | Class II | |
| K902898 | Argenco M-4 Type II Dental Gold Alloy | Argen Precious Metals, Inc. | EJT | Class II | |
| K902582 | Allergan Humphrey A/b Scan , Model 835 | Allergan Humphrey | IYO | Class II | |
| K902489 | Modified Molteno(tm) Implants | Iop, Inc. | KYF | Class II | |
| K902451 | Long-Life Y-Set Cat. No. 48-6366-8 | National Medical Care, Medical Products Div., Inc. | KDJ | Class II | |
| K902447 | Coring Needle (Trephine, Orthopedic) | Biomedtrix, Ltd. | HWE | Class I | |
| K902283 | The Nautilus Nasal Implant | Applied Biomaterial Technologies | FZE | Class II | |
| K902277 | Bard Extracorporeal Circulation Cannulae | C.R. Bard Inc | DWF | Class II | |
| K902260 | Scale-Tronix Incubator Scale Model:4050 | Scale-Tronix, Inc. | FRW | Class I | |
| K902236 | Reads Anti-Cardiolipin Semi-Quantitative Test Kit | Biosearch Medical Products, Inc. | GGW | Class II | |
| K902205 | Otoscope | Truphatek, Ltd. | ERA | Class I | |
| K901983 | Oxygen, Air & Vacuum Coupler & Nitrous-Oxide Coup. | Medical Fittings, Inc. | BYX | Class I | |
| K901961 | Oxygen Coupler, Air Coupler & Vacuum Coupler | Medical Fittings, Inc. | BYX | Class I | |
| K901869 | Degufill (R) H | Degussa AG | EBF | Class II | |
| K901868 | Degufill (R) M | Degussa AG | EBF | Class II | |
| K901831 | Precision Medical Oxygen Regulator | Precision Medical, Inc. | CAN | Class I | |
| K901728 | One-Lung CPAP Device | Vital Signs, Inc. | BYE | Class II | |
| K901726 | Lumiscope Micro 100 | Lumiscope Co., Inc. | GZJ | Class II | |
| K901626 | H.n. Metal Backed Acetabular Cup, Noncemented | Med-Tek Corp. | KWA | Class III | |
| K901205 | Models Ir103,ir107,ir104,ir205 (Add'l Application) | Niic U.S.A., Inc. | GEX | Class II | |
| K901037 | Visioner 21-a | J. Morita USA, Inc. | EKS | Class I | |
| K900998 | Interventional Medical Y Adapter W/adjust. Valve | Intec Medical, Inc. | DQY | Class II |