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 |
|---|---|---|---|---|---|
| K881087 | Lifeguard Single Use Manual Resuscitators | Lifeguard Medical Products, Inc. | BTM | Class II | |
| K881086 | Lifeguard Mouth to Mask Resuscitator | Lifeguard Medical Products, Inc. | BTM | Class II | |
| K881014 | The Karl Storz Mini 9000 Solid State Ccd Video Cam | Karl Storz Endoscopy-America, Inc. | FWF | Class I | |
| K880959 | Lifeguard Gas Sampling Line for Mass Spectrometry | Lifeguard Medical Products, Inc. | BZO | Class I | |
| K880721 | 6400St Interface Module-Rs232 | Bird Products Corp. | CBK | Class II | |
| K880660 | Surgitek Super Double J Ureteral Stent Kit | Surgitek | FAD | Class II | |
| K880659 | Teknar Proscan Accessory Probe | Teknar, Inc. | IYO | Class II | |
| K880455 | At Ease Adult Diaper | Hospital Specialty Co. | EYQ | Class I | |
| K880337 | Macbick Disposable Barium Enema Syst 4800 & 4700 | Plasco, Inc. | FCE | Class I | |
| K880256 | Model 4060 N Nd:yag Laser for Gastroenterology Use | Sharplan Lasers, Inc. | LNK | Class II | |
| K880203 | Herman Cannula Set | Mizuho Orthopedic Systems Inc | HRX | Class II | |
| K880201 | Replacement Silicone Gastrostomy Tube Kit #87600 | Superior Healthcare Group, Inc. | KNT | Class II | |
| K880193 | Model 4060 N Nd:yag Laser for Urological Use | Sharplan Lasers, Inc. | LNK | Class II | |
| K880183 | Portable Therapeutic Liquid Oxygen Unit | Essex Cryogenics of Missouri, Inc. | BYJ | Class II | |
| K880054 | Cpu 1100 Ventilator | GE Healthcare | CBK | Class II | |
| K880051 | Enteral Bag/set | Churchill Corp. | KNT | Class II | |
| K880026 | Churchill 0.22 Micron Liquid Compact Filter Sets | Churchill Corp. | FPB | Class II | |
| K880025 | Churchill 0.22 Micron Liquid Filter Sets | Churchill Corp. | FPB | Class II | |
| K875241 | Civco Seed Implant Needle Guide | CIVCO Medical Instruments Co., Inc. | IYO | Class II | |
| K875221 | Tooth Preserving System | Biological Rescue Products, Inc. | KJF | Class I | |
| K874936 | Medsurg Percutaneous Endoscopic Gastrostomy Tray | Medsurg Industries, Inc. | KNT | Class II | |
| K874759 | 13L81 Disposable Sphincter Electrode, 13L33 Cable | Dantec Electronics, Inc. | FAP | Class II | |
| K874758 | Dantec 13L40 St. Marks's Pudendal Electrode | Dantec Electronics, Inc. | FAP | Class II | |
| K873696 | Bodai Neo2-Safe(tm) | B & B Medical Technologies, Inc. | BZA | Class I | |
| K873380 | Vitalert 1000 Monitoring System | Draeger, Inc. | CCK | Class II | |
| K881459 | Nanolas Nd:yag Ophthalmic Laser | Biophysic Medical, Inc. | LOI | Class III | |
| K881385 | Psoralite Phototherapy Treatment Booth/panel | Psoralite Corp. | FTC | Class II | |
| K881371 | Cox Rapid Heat Transfer Sterilizer W/12 Min. Cycle | Cox Sterile Products, Inc. | KMH | Class II | |
| K881232 | Surgin Eye Shield | Surgeon Surgical Instrumentation, Inc. | HOY | Class I | |
| K880977 | Adr-2000 Ambulatory Data Recording System | Aaron Laboratories, Inc. | IKN | Class II | |
| K880976 | Al-200B Muscle Activity Integrator | Aaron Laboratories, Inc. | IKN | Class II | |
| K880951 | Disposable Coaxial Bipolar Pen P/n 00150 | Advanced Surgical Products, Inc. | GXI | Class II | |
| K880925 | Disposable Wet Field Eraser | Advanced Surgical Products, Inc. | GXI | Class II | |
| K880815 | Dx101-T Ultrasonic Surgical System | Niic U.S.A., Inc. | LFL | Unclassified | |
| K880814 | Dx101 Ultrasonic Surgical System | Niic U.S.A., Inc. | LFL | Unclassified | |
| K880459 | 480 High-Flow Ultrafiltration Control Dialysate | Cd Medical, Inc. | FKP | Class II | |
| K880153 | Polyderm A+b(tm) | Laivan Corp. | NAD | Class I | |
| K880027 | Churchill 1.2 Micron Liquid Filter Set | Churchill Corp. | FPB | Class II | |
| K875364 | Modified Pca Infuser | BD Becton Dickinson Vacutainer Systems Preanalytic | FRN | Class II | |
| K875338 | Chrys(tm) Model Med-Max | California Laboratories, Inc. | GEX | Class II | |
| K875333 | Surgitek Npt Monitor | Surgitek | LIL | Unclassified | |
| K875276 | Port-a-Cath(r) Implantable Drug Delivery System | Pharmacia Deltec, Inc. | LJT | Class II | |
| K875253 | Bfgoodrich Biothane Non-Adherent Dressing | The Bfgoodrich Co. | NAD | Class I | |
| K875039 | Nd:yag 100 Surgical Laser for Gastro. and Urology | Surgilase, Inc. | LNK | Class II | |
| K875003 | Prisma Disposable Pupil Centering Cannula | Advanced Surgical Products, Inc. | HMX | Class I | |
| K875002 | Prisma Disposable Viscoelastic I/a Cannula | Advanced Surgical Products, Inc. | HMX | Class I | |
| K875001 | Prisma Disposable Blunt Irrigating Cystotome | Advanced Surgical Products, Inc. | HNY | Class I | |
| K875000 | Prisma Disposable Endo-Ocular Probe | Advanced Surgical Products, Inc. | HQF | Class II | |
| K874999 | Prisma Disposable Atkinson Retrobulbar Needle | Advanced Surgical Products, Inc. | HMX | Class I | |
| K874998 | Prisma Disposable U-Shaped Cannula | Advanced Surgical Products, Inc. | HMX | Class I |