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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K863896 | Austin Moore Hip Prosthesis | Kirschner Medical Corp. | |||
| K863854 | P.m.d. Intramedullary Cement Restrictor Plug | Precision Medical Devices, LLC | |||
| K863565 | Mentor Alloplastic Spermatocele | Mentor | LQS | Unclassified | |
| K862878 | Free & Active(tm) Absorbent Pads | Convatec, A Division of E.R. Squibb & Sons | EYQ | Class I | |
| K862877 | Male Urinary Stress Pad* | Convatec, A Division of E.R. Squibb & Sons | EYQ | Class I | |
| K862727 | Zinetics Gastrometer (Tm) | Zinetics Medical Technology Corp. | FFT | Class I | |
| K862598 | Laserscope Omni Plus Photosurgical System/supplem | Laserscope | LNK | Class II | |
| K861699 | Catheter Valves Kv 100 & Kv 100Eh | Max Staubli, Ltd. | KOD | Class II | |
| K864307 | Max-I-Probe Peridontal/endodontic Probe(tm) (Modi) | Smith & Nephew, Inc. | EIC | Class I | |
| K864215 | Prophy Care Solution | Imd, Inc. | EJR | Class I | |
| K864096 | Dream Dam | Dental Dam, Inc. | EIE | Class I | |
| K863987 | Bi-Temp Temperature Monitor | Respiratory Support Products, Inc. | |||
| K863984 | Model 320 Two Channel Audiometer | Virtual Corp. | EWO | Class II | |
| K863979 | Microscreen I Hearing Tester | Microscreen | EWO | Class II | |
| K863882 | Opalux Visible Light Cured Anterior Composite | Coe Laboratories, Inc. | EBF | Class II | |
| K863672 | Model (Mb-700) Blood Pressure Monitor | Sharp Electronics Corp. | DXN | Class II | |
| K863593 | Sarns Safety Loop | 3M Health Care, Sarns | DWD | Class II | |
| K863541 | Stockert-Shiley Caps Hlm Interface | Shiley, Inc. | DTQ | Class II | |
| K863515 | Modified Sarns Oxygenator System | 3M Health Care, Sarns | DTZ | Class II | |
| K863124 | Model 8 EEG Preamplifier | Micro Tronics Corp. | GWQ | Class II | |
| K862200 | Fortec Mi-100, Blood Pressure Meter | Fortec Electronic Corp./Nam Tai | DSK | Class II | |
| K860801 | Model 8400 W/modifications (Spectrum 32) | Cadwell Laboratories, Inc. | GWE | Class II | |
| K864386 | Luxtec Loupes for Surgical Vision | Luxtec Corp. | FSP | Class I | |
| K864371 | Surgical Skin Marker | Myocure, Inc. | FZZ | Class I | |
| K864193 | Gilbaugh Aspirating Biopsy Syringe/needle/gun | Gaw, Inc. | GDM | Class I | |
| K864165 | Mbk Surgeons'(sterile & Non-Sterile) Surg Gloves | Mbk Medical Gloves Co., Ltd. | KGO | Class I | |
| K864160 | Leukoplast(r) Porous and Sport Tape | Beiersdorf, Inc. | KGX | Class I | |
| K863389 | United Wound Covering, Package of 5 | United Medical Inc | FRO | Unclassified | |
| K862815 | Laser Surgical Rod | Lifestream Int'L, Inc. | GEX | Class II | |
| K862720 | Vasoflo-3 & Extravascular Blood Flow Probes | Sonicaid, Inc. | DPW | Class II | |
| K862714 | Bilateral Impedance Plethysmograph, Bip(tm) | Electro-Diagnostic Instruments | DSB | Class II | |
| K861023 | Dopplex, Pulsed/continuous Wave Doppoler | Diagnostic Electronics Corp. | DPW | Class II | |
| K855048 | Norelco Digital Blood Pressure Meter Hc3001 | Philips Park | DXN | Class II | |
| K854279 | Norelco Electronic Digital Bp Meter Hc3030 | Philips Park | DXN | Class II | |
| K864204 | Vocaid, Electronic Vocal Aid | Texas Instruments, Inc. | ILQ | Class II | |
| K864109 | C' Airecush Seat Cushion | Medical Industries America, Inc. | KIC | Class I | |
| K864108 | Push Cush | Medical Industries America, Inc. | KIC | Class I | |
| K864013 | Model Q55xt Powered Treadmill | Quinton, Inc. | IOL | Class I | |
| K863865 | Tensotape Surgical Adhesive Tape | Smith & Nephew, Inc. | |||
| K862803 | Chesebrough Pond's Hydrocolloid Dressing | Chesebrough-Pond'S U.S.A. Co. | FRO | Unclassified | |
| K862448 | Flow Generator for Sleep Apnea, Lds 1500 | Life Design Systems, Inc. | BZD | Class II | |
| K864274 | Thromboplastin.r | American Dade | GJS | Class II | |
| K864273 | Thromboplastin.c | American Dade | GJS | Class II | |
| K864272 | Thromboplastin.fs | American Dade | GJS | Class II | |
| K864269 | Model 35-B All Level Cot | Ferno-Washington Inc | FPO | Class II | |
| K864186 | Hill-Rom Century Cc Models 892 &894 (Radiolucent) | Hill-Rom Inc. | FNL | Class II | |
| K864172 | Hill-Rom Century Cc, Models 891 & 893 Weighing Sys | Hill-Rom Inc. | FNL | Class II | |
| K864157 | Opti-Brush | Willmar Contact Lens Clinic | LPN | Class II | |
| K864127 | Mechanical Oxygen Regulator | Travomed, Inc. | NFB | Class II | |
| K864080 | Ubi Magiwel(tm) Fsh Quantitative | United Biotech | CGJ | Class I |