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 |
|---|---|---|---|---|---|
| K913010 | Bactidrop (Tm) Nitrate B | Remel Inc | JTO | Class I | |
| K912974 | Mam-3Rm-a Mammographic X-Ray System | Elscint, Inc. | IZH | Class II | |
| K912927 | Amcath Disposable Trocar and Trocar Sleeve | Intl. Medical, Inc. | GCJ | Class II | |
| K912790 | Surgical Gown | Unicor Federal Dept. of Justice | FYE | Class I | |
| K912517 | Floor Mount Tubestand Performer, 6610.101/S-9109 | Continental X-Ray Corp. | KPR | Class II | |
| K912515 | Floor Mount Tubestand-Performer-N 6610.102/S-9110 | Continental X-Ray Corp. | KPR | Class II | |
| K912097 | Auto Suture Endoscopic Fascia Stapler | United States Surgical, A Division of Tyco Healthc | GCJ | Class II | |
| K912087 | Acl Coagulation Systems,models 1000,2000,3000,Plus | Instrumentation Laboratory Co. | JPA | Class II | |
| K912005 | Codman Skull Pins (Adult & Child), Reusable | Cerenovus, Inc. | HBL | Class II | |
| K911647 | Ngm Gas Module | Datex Division Instrumentarium Corp. | CBQ | Class II | |
| K911399 | Nasal CPAP (Continuous Positive Air Pressure Syst) | Aequitron Medical, Inc. | DZD | Class I | |
| K911312 | Suction/irrigation Tube & Tube with Channel | Northgate Technologies Inc. | GEI | Class II | |
| K911127 | Collimaster-90 | Varian Assoc., Inc. | IZW | Class II | |
| K910786 | Trocar (Faller Stylet) | Accurate Surgical Instruments Co. | FJS | Class II | |
| K910647 | Ximatron/ct Option | Fischer Imaging Corp. | KPQ | Class II | |
| K910004 | Furui Shunt, 2-Way and 3-Way | Theramed, Inc. | DWF | Class II | |
| K913865 | Urine Thc Direct Ria Kit (I-125) | Immunalysis Corporation | LAT | Class II | |
| K913781 | Qualitone 48Pp-Agc-I, Behind the Ear Hearing Aid | Qualitone | ESD | Class I | |
| K913771 | Elegance - Ked, Behind the Ear Hearing Aid | Qualitone | ESD | Class I | |
| K913707 | Abbott Quickstart Creatinine Test(crea) Item# 5A28 | Em Diagnostic Systems, Inc. | CGX | Class II | |
| K913592 | Qualitone 46Pp-Agc-I | Qualitone | ESD | Class I | |
| K913347 | Palmer Arch Suppressor | Smith & Nephew Dyonics, Inc. | HRX | Class II | |
| K913135 | Lm-300Twin | Leisegang Medical, Inc. | FSW | Class II | |
| K913009 | Bactidrop(tm) Indole (Kovacs) | Remel Inc | JTO | Class I | |
| K913004 | Bactidrop(tm) Spot Indole | Remel Inc | JTO | Class I | |
| K913001 | Bactidrop(tm) Desoxycholate (10%) | Remel Inc | JTO | Class I | |
| K912793 | Slt Multidimensional Contact Laser System (Cls) | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K912702 | Plastic Attachable Dual Port | Davol, Inc. | LJT | Class II | |
| K912614 | Andrew Laparoscopic Surgical Instruments | Andrew Surgical | GEI | Class II | |
| K912548 | Lemaitre-Bookwalter Vessel Devices | Vascutech, Inc. | DWP | Class II | |
| K912235 | Models 432-03 & 433-03 Implant Endocard Pac Lead | Intermedics, Inc. | DTB | Class III | |
| K911912 | Sr1 T3 Uptake Enzyme Immunoassay(mag Solid-Phase) | Serono-Baker Diagnostics, Inc. | KHQ | Class II | |
| K911747 | Pro-Guide | American Interventional Technology | DQY | Class II | |
| K905263 | Utah Essu | Utah Medical Products, Inc | HGI | Class II | |
| K905059 | High Speed Magnetic Stimulator | Cadwell Laboratories, Inc. | GWF | Class II | |
| K912202 | Rich-Mar Model 25 Ultrasound | Rich-Mar Corp. | IMI | Class II | |
| K910965 | Echomark Csi Interface | Catheter Sciences Co. | LIT | Class II | |
| K905747 | Leep System 6000 Electrosurgical Unit and Accessor | Coopervision Surgical | HGI | Class II | |
| K904871 | Medi-Kleer | North American Marketing Corp. | OCT | Class II | |
| K904622 | Hearing Checker(tm), Desktop Model | Qualitone Hearing Aids and Audiometers | EWO | Class II | |
| K913870 | 5Mm Microscissors | Endovations | GCJ | Class II | |
| K913564 | Hercules 5000 and Hercules 5040 Nd:yag Laser Syste | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K913410 | Emit(r) 2000 Gentamicin Assay/calibrators | Syva Co. | DMB | Class II | |
| K913155 | Leg Urinal | Ezmt Valve Co., Inc. | GAQ | Class II | |
| K913065 | Shimadzu X-Ray High Voltage Generator Ud150l | Shimadzu Medical Systems | IZO | Class I | |
| K913064 | Shimadzu X-Ray High Voltage Generator Xud 150L | Shimadzu Medical Systems | IZO | Class I | |
| K913063 | Shimadzu X-Ray High Voltage Generator Xud150b-10 | Shimadzu Medical Systems | IZO | Class I | |
| K913062 | Shimadzu X-Ray High Voltage Generator Ud150b-10 | Shimadzu Medical Systems | IZO | Class I | |
| K913018 | Med-E-Jet Injector | Med-E-Jet D | KZE | Class II | |
| K913005 | Bactidrop(tm) Lactophenol Aniline Blue | Remel Inc | JIO | Class II |