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 |
|---|---|---|---|---|---|
| K924130 | Coffman Implant Tomograph | Coffman Dental | EHD | Class II | |
| K923552 | Kodak X-Omat Fs-1A Processor | Eastman Kodak Company | IXW | Class II | |
| K923107 | Body Band Restraint Strap Set | Cook, Inc. | JAA | Class II | |
| K923067 | Sens-a-Ray | Regam Medical Systems | EHD | Class II | |
| K923025 | Signa Breast Coil and Array Accessory | GE Healthcare | LNH | Class II | |
| K922999 | Segal Reusable Electrode | Bernsco Surgical Supply, Inc. | GEI | Class II | |
| K922977 | Exposet | S & S Inficon, Inc. | JAA | Class II | |
| K922591 | Urological C-Arm Table, Model #056-450 | Biodan Medical Systems, Ltd. | IXR | Class II | |
| K922470 | Ies, Image Enhancement System | Open Mri, Inc. | LNH | Class II | |
| K922286 | Model Xct-900 Pqct X-Ray Bone Densitometer | Norland Corp. | KGI | Class II | |
| K921991 | Plato Radiation Therapy Planning System | Nucletron-Oldelft Corp. | IYE | Class II | |
| K921341 | Acuson V714or Transducer | Acuson Corp. | ITX | Class II | |
| K921297 | Drager Dve 4000 Series System | Alm Surgical Equipment, Inc. | FQO | Class I | |
| K912210 | Pro-Chill Stimpack | Tko, Inc. | GXY | Class II | |
| K911238 | Tahoe Suction Irrigator | Tahoe Pro Instruments | GCX | Class II | |
| K901615 | Pulmocath Intrabronchial Catheter | Omnitron Intl., Inc. | JAQ | Class II | |
| K925203 | Technicon Chem 1(R)/chem 1+(Tm) Software Ver 11.1 | Kulzer GmbH | JJQ | Class I | |
| K925041 | Mckernan Atraumatic Forceps | Aslan Medical Technologies, Ltd. | GCJ | Class II | |
| K924993 | Glenroe Band Seating Contouring Instrument | Glenroe Technologies | ECS | Class I | |
| K924812 | 3M Curing Light Xl 3000 | 3M Company | EBZ | Class II | |
| K924693 | Olympus Bun Reagent | Olympus Corp. | CDQ | Class II | |
| K924645 | Transcend Series 6000 Debonding Instruments | Unitek Corp. | JEX | Class I | |
| K924572 | Emds Glucose (Glu-Hk) Test, Item 65415 | Em Diagnostic Systems, Inc. | CFR | Class II | |
| K924373 | Accuflate Accessorie Cart W/iv Pole and Clamp | Instrumed, Inc. | BZN | Class I | |
| K924360 | Impra Flex Grafts (Various Product Code Numbers) | Impra, Inc. | DYF | Class II | |
| K924259 | Medix Biotech Bestest(tm) Hcg-Urine, Cat# B1h0100 | Medix Biotech, Inc. | JHI | Class II | |
| K924102 | Needle | United States Endoscopy Group, Inc. | FBK | Class II | |
| K923896 | Hercules Model 5060 and 5100 Nd:yag Laser Systems | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K923845 | Dexide Laparoscopic Accessories | Dexide, Inc. | GEI | Class II | |
| K923832 | Pharmacia Cap System Ige Feia -- Modification | Kabi Pharmacia, Inc. | DGC | Class II | |
| K923563 | Symbiosis Suction-Irrigator | Boston Scientific Corporation | GEI | Class II | |
| K922522 | Monoject Safety Syringe, 1 Cc, 3Cc and 12 Cc Sizes | Sherwood Medical Co. | FMF | Class II | |
| K922515 | Profeel Anatom Surg Gloves (Powder Free/hypoaller) | Wembley Rubber Products (M) Sdn Bhd | KGO | Class I | |
| K922424 | Access Surgical Int'l Endoscopic Surgical Instrum. | Access Surgical Intl., Inc. | GCJ | Class II | |
| K921748 | Model 2000 Dental Air Abrasive System | Texas Airsonics, Inc. | KOJ | Class II | |
| K921659 | Ultra Low Porosity Dacron Woven Patch | Intervascular, Inc. | DXZ | Class II | |
| K920036 | Surecath Port Access Catheter | Ivion Corp. | LJT | Class II | |
| K910993 | Morrey Elbow Fixator | Howmedica Corp. | KTT | Class II | |
| K925008 | Rln Nerve Locator/monitor; Model a | Rln Systems, Inc. | ETN | Class II | |
| K924888 | P54 Hearing Aid | Electone, Inc. | ESD | Class I | |
| K924887 | P54-0 Behind the Ear Hearing Aid | Electone, Inc. | ESD | Class I | |
| K924739 | The Dentist's Tooth Polisher | Ranir/Dcp Corp. | JEQ | Class I | |
| K924657 | True/flex Metatarsal Rods | Applied Osteo Systems, Inc. | KTW | Class II | |
| K924656 | True/ Flex Fibula Rods | Applied Osteo Systems, Inc. | HSB | Class II | |
| K924593 | Diagnost 76 Family*r/f Systems - Release 4.4 | Philips North America LLC | IXL | Class II | |
| K924492 | Poly-Dial Inserts | Joint Medical Products Corp. | LPH | Class II | |
| K924115 | Ultima All Uhmwpe Cemented Acetabular Cups | Johnson & Johnson Orthopaedics, Inc. | JDI | Class II | |
| K924106 | Biopsy Forceps | United States Endoscopy Group, Inc. | KNW | Class II | |
| K924105 | Snare Flexible | United States Endoscopy Group, Inc. | FDI | Class II | |
| K924104 | Cytology Brush | United States Endoscopy Group, Inc. | FDX | Class II |