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 |
|---|---|---|---|---|---|
| K895918 | Sterile Disposable Infratip | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K895907 | Hysteroflator 2001 | Cabot Medical Corp. | HIG | Class II | |
| K895894 | Profil Condom (Rubber Latex) | Rfsu | HIS | Class II | |
| K895869 | Gyroscan T5 Mobile | Philips North America LLC | LNH | Class II | |
| K895837 | Medilase System 2010L Laser Lithotriptor | Medical Laser, Inc. | GEX | Class II | |
| K895636 | Dimension Revision Total Hip System | Kirschner Medical Corp. | JDI | Class II | |
| K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | IYO | Class II | |
| K895442 | The X-Ray Digitizer, Altek Model Act20020-Bl | Altek Corp. | KPQ | Class II | |
| K895408 | Opsite*wound (Flexigrid Application System) | Smith & Nephew United, Inc. | KGX | Class I | |
| K895399 | Kim Modular Femoral Hip Prosthesis | Dow Corning Wright | LZO | Class II | |
| K895028 | Birds'n Bees Condoms | Rfsu | HIS | Class II | |
| K894887 | Shimadzu Whole Body X-Ray CT Scanner Sct-3000Tf | Shimadzu Medical Systems | JAK | Class II | |
| K894643 | Rt-125 Rough Terrain Mobile X-Ray Unit | Lorad Medical Systems, Inc. | IZL | Class II | |
| K894534 | Condom (Rubber Latex) Okeido | Rfsu | HIS | Class II | |
| K893994 | If2000 Electrical Muscle Stimulator Unit | Rich-Mar Corp. | IPF | Class II | |
| K893834 | Accumed Latex Surgical Glove | Accurate Medical Devices, Inc. | KGO | Class I | |
| K893136 | Surgi-Pak for Arthroscopic Acromioplasty | Dyonics, Inc. | HRX | Class II | |
| K892711 | Quantim 2000I Digital Image Analysis System | Quantitative Cardiac Systems (Qcs), Inc. | LLZ | Class II | |
| K896632 | Medtronic Model 5401B Test Cable | Medtronic, Inc. | DTC | Class II | |
| K896533 | Spenco Breast Forms | Spenco Medical Corp. | KCZ | Class I | |
| K896490 | Curity(r) Disposable Laparotomy Sponges | Kendall Healthcare Products Co. Div.Of Tyco Health | EFQ | Unclassified | |
| K896386 | Minimon 7133B Patient Monitor | Kontron Instruments, Inc. | DPS | Class II | |
| K896221 | Cards O.s.(tm) Strep a | Pacific Biotech, Inc. | GTZ | Class I | |
| K896155 | Red Dot Cardiac Sensor System | 3M Company | DRX | Class II | |
| K896115 | Tampon, Petal Soft Plastic Appli., Deodorant Super | Tambrands Inc. | HIL | Class II | |
| K896114 | Tampon, Petal Soft Plastic Appli., Super Absorb. | Tambrands Inc. | HEB | Class II | |
| K896113 | Tampon, Petal Soft Plastic Applicator, Super Plus | Tambrands Inc. | HEB | Class II | |
| K896112 | Tampax Tampon, Flushable Applicator, Super Plus | Tambrands Inc. | HEB | Class II | |
| K895916 | Pe Intercardiac Mapping System (Icms) | Prucka Engineering, Inc. | DRF | Class II | |
| K895691 | Vascular Clamp | Applied Vascular Devices, Inc. | DXC | Class II | |
| K895581 | Model: Ir205 Articulated Surgical Laser | Niic U.S.A., Inc. | GEX | Class II | |
| K895444 | The Waverly Wedge(tm) Inflatable Air Cushion | Mcvicar Enterprises, Ltd. | INW | Class I | |
| K895292 | Lyme Igg Elisa Test System | Zeus Scientific LLC | LSR | Class II | |
| K895232 | Model Eli-100/St Electrocardiograph | Mortara Instrument, Inc. | LOS | ||
| K895199 | Biasol Liquid Concentrates, Add'l Acid Concentrate | Baxter Healthcare Corporation | KPO | Class II | |
| K895009 | Gel-Tac(r) | Padeco, Inc. | LDD | Class II | |
| K894925 | Amcath Ureteral Dilators Models 7100,7110,7120 | Intec Medical, Inc. | EZN | Class II | |
| K894736 | Mt96000 Paper Chart Recorder | Astro-Med, Inc. | DSF | Class I | |
| K894662 | Test One | Primed Products, Inc. | IKK | Class II | |
| K894356 | Disp. Polymer (Hydrogel) External Pacing & Defib. | Phycon | LDD | Class II | |
| K894216 | Haemophilus Test Medium (Htm)agar | BD Becton Dickinson Vacutainer Systems Preanalytic | JSO | Class II | |
| K892649 | Verimed Myoexorciser III (Myo III) | Verimed Holdings, Inc. | HCC | Class II | |
| K896451 | Modified Cedia(tm) Cortisol Assay | Microgenics Corporation | CGR | Class II | |
| K896417 | Kontron Kolormon 7250 Patient Monitor | Kontron Instruments, Inc. | DPS | Class II | |
| K896329 | D-Chem Total T4 Test Kit for Thyroxine Quantita. | Photec Diagnostics, Inc. | KLI | Class II | |
| K896270 | Amerlite Estradiol-60 Assay Lan.0081/2081 | Amersham Corp. | CHP | Class I | |
| K896073 | Cholesterol, Universal Et | Enzyme Technology, Inc. | CHH | Class I | |
| K895936 | Easylyte Sodium/potassium/chloride Analyzer | Medica Corp. | JGS | Class II | |
| K895873 | Calcium, Catalogue Number140-20 | Diagnostic Chemicals, Ltd. (USA) | CJY | Class II | |
| K895651 | Marquette 1200 Defibrillation Pads | Marquette Electronics, Inc. | LDD | Class II |