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 |
|---|---|---|---|---|---|
| K882661 | Acumed 9000 Etco(2) Monitor | Acumed Technologies, Inc. | CCK | Class II | |
| K882159 | 522 Intelligent Pump | Kendall Mcgaw Laboratories, Inc. | FRN | Class II | |
| K881834 | Model Ssd-870 Diagnostic Ultrasound Imaging System | GE Medical Systems Information Technologies, Inc. | IYO | Class II | |
| K881767 | Viggo Insuflon | GE Healthcare | FOZ | Class II | |
| K881270 | Gambro Multipurpose System Mps-10 | Gambro, Inc. | FII | Class II | |
| K880769 | Breathing Circuit W/heated Wire | Dryden Corp. | BZE | Class II | |
| K883357 | Model 1080 Roller Massage Table | Excel Medical Products, Inc. | JFB | Class II | |
| K883351 | Percutaneous Endoscopic Gastrostomy Feeding Tube | Gastrotech, Inc. | KNT | Class II | |
| K883338 | Surgical Sealant Applicator | Micromedics, Inc. | KYZ | Class I | |
| K883336 | Gastrostomy Feeding Tube | Gastrotech, Inc. | KNT | Class II | |
| K883299 | Suture Retention Device | Edwards Orthopaedics Div., Baxter Healthcare Corp. | KGS | Class I | |
| K883295 | Chop Spine Frame | Avec Scientific Design Corp. | LWG | Class I | |
| K883244 | Pristine Xtra, Surgeon's Glove | Japan World Medical Supply | KGO | Class I | |
| K883064 | Massage Machine (Cat. Em-01 Ule 111756) | Emrad, Ltd. | ISA | Class I | |
| K882942 | Laser Mixture | Swisco, Inc. | GEX | Class II | |
| K882766 | Emds Acetaminophen Calibrator No. 67636/95 | Em Diagnostic Systems, Inc. | DLG | Class I | |
| K882114 | Amisco U-100 Insulin Syringe | American Intl. Medical Supply Co. | FMF | Class II | |
| K881826 | Endo-Ice | The Hygenic Company, LLC | EAT | Class II | |
| K881775 | Bd Microfine IV Pen Injector | BD Becton Dickinson Vacutainer Systems Preanalytic | FMF | Class II | |
| K875049 | Md Strips Bg | Amatech International, Inc. | CGA | Class II | |
| K873121 | Ge Integrated Diagnostic System (Drs.prs) | General Electric Co. | LMD | Class I | |
| K883233 | Ev Monocanalicular Stent (Tm) | Grace Medical, Inc. | OKS | Unclassified | |
| K883197 | IOL Implantation Forceps | D & D Surgical | HNR | Class I | |
| K882402 | Retractive Incision Micrometer (Rim) Guage | Optical Center | HNN | Class I | |
| K881518 | Infusion Handle | B&B Medical Assoc., Inc. | KYG | Class I | |
| K881517 | B & B I/a Handpiece | B&B Medical Assoc., Inc. | KYG | Class I | |
| K872786 | Sunglasses | Quality Sunglasses, Ltd. | HQY | Class I | |
| K871875 | Model 5050 Surgilaser for Ob-Gyn Use | Lasermatic, Inc. | HHR | Class II | |
| K883414 | Laryngoscope Blades | Truphatek, Ltd. | CCW | Class I | |
| K882943 | Meda One-Step | Medical Electronic Assn. | GZJ | Class II | |
| K882906 | Dentascan | Mpdi, Inc. | JAK | Class II | |
| K882900 | Mechanical Tables and Accessories | Rifton | INW | Class I | |
| K882833 | The Berg Resuscitation Apparatus | Hursch Ent., Inc. | BTL | Class II | |
| K882675 | Ath Metal:uhmwpe Total Hip System | Kinamed Inc | KWA | Class III | |
| K882454 | Luhr Micro System | Howmedica Corp. | HRS | Class II | |
| K882175 | Hr-2000 W/suffixes B,c,d, Cardio & Digi Loop, Ddvp | Eigen | JAA | Class II | |
| K882168 | External Pacemaker 2000 (Ep2000) | Unomed, Inc. | DRO | Class II | |
| K882162 | Nidek US-3000 | Nidek, Inc. | IYO | Class II | |
| K882079 | Respironic's Infant Secureeasy | Respironics, Inc. | CBH | Class I | |
| K881663 | Oxygen/temperature Analyzer Model 300 Series | Salter Labs | CCL | Class II | |
| K881055 | ECG Monitor and Respiration Pacer | D. E. Hokanson, Inc. | DPS | Class II | |
| K880762 | Taper Flex-Tip Steerable Guidewire | Target Therapeutics | DQX | Class II | |
| K880761 | Taper-22 Steerable Guidewire | Target Therapeutics | DQX | Class II | |
| K880722 | Coating for Wire Guide | Cook Inc. | DQX | Class II | |
| K880562 | Additional Claims to Dental Restorative Comp. Kit | Macrochem Corp. | DYH | Class II | |
| K880301 | 3000 Physiological Monitor | Datascope Corp. | DXG | Class II | |
| K883339 | Clipper Power Drive Wheelchair | Everest & Jennings, Inc. | ITI | Class II | |
| K883275 | Swede Elite, Mechanical Wheelchair | Etac Us, Inc. | IOR | Class I | |
| K883228 | Sonicator 720 (Model Me720) | Mettler Electronics Corp | IMI | Class II | |
| K883216 | Bunn Model 50 Oxygen Flow Controller | The John Bunn Co. | NFB | Class II |