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 |
|---|---|---|---|---|---|
| K993925 | Wako L-Type Un Test | FUJIFILM Healthcare Americas Corporation | CDQ | Class II | |
| K993208 | Stc Methamphetamine Intercept Micro-Plate Eia, Model 1104I | OraSure Technologies, Inc. | LAF | Class II | |
| K992918 | Stc Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I | OraSure Technologies, Inc. | DKZ | Class II | |
| K992720 | Rapidone- Benzodiazepine Test | American Bio Medica Corp. | JXM | Class II | |
| K992451 | Rapidone- Barbiturate Test | American Bio Medica Corp. | DIS | Class II | |
| K000858 | Wehrs Incus-Stapes | Gyrus Ent LLC | ETB | Class II | |
| K000797 | Obl 2.0 Mm Mini Tac Anchor, Model 10-1629-01 | Orthopaedic Biosystems, Ltd. | JDR | Class II | |
| K000662 | Randox Ferritin | Randox Laboratories, Limited | DBF | Class II | |
| K000459 | Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog No. Df 96A | Siemens Healthcare Diagnostics Inc. | DIS | Class II | |
| K000262 | Bohn Femoral Component | Biomet Manufacturing Corp | MEH | Class II | |
| K000080 | Asnis III Cannulated Screw System | Howmedica Osteonics Corp | HWC | Class II | |
| K000027 | Insufflation Needle, Model R65-933 | A & A Medical, Inc. | HIF | Class II | |
| K993552 | Isoseed Pd-103 | Eckert & Ziegler Bebig GmbH | KXK | Class II | |
| K993512 | Datex-Ohmeda Tuffsat 3000 Pulse Oximeter | GE Healthcare | DQA | Class II | |
| K993412 | Bitx Probes | Everest Medical Corp. | GEI | Class II | |
| K992392 | Rtlx | Infimed, Inc. | MUH | Class II | |
| K991383 | Hydrocision Debdridement System | Hydrocision, Inc. | FQH | Class II | |
| K000731 | Modification to Rta Retinal Thickness Analyzer | Talia Technology, Ltd. | HLI | Class II | |
| K000722 | Unipolar Needles | Pajunk GmbH Medizintechnologie | BSP | Class II | |
| K000715 | Envoy and Vista Brite Tip | Cordis US Corp. | DQY | Class II | |
| K000483 | Randox Albumin | Randox Laboratories, Limited | CJW | Class II | |
| K000454 | Dimex 2 | Planmeca Oy | MUH | Class II | |
| K000424 | S51d Digital Endoscopy Camera | Sopro | GCJ | Class II | |
| K000423 | S52d Digital Video Laparoscope | Sopro | GCJ | Class II | |
| K000422 | S57d Digital Operating Room Camera | Sopro | GCJ | Class II | |
| K000305 | Hardydisk, Cefoxitin, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K000202 | Cortek Laparoscopes | Cortek Endoscopy, Inc. | GCJ | Class II | |
| K000026 | Apple Medical One-Touch Uterine Sampler | CooperSurgical, Inc. | HHK | Class II | |
| K993970 | Micrins Microsurgical Suture | Micrins Surgical, Inc. | GAR | Class II | |
| K993041 | Olympus Xcyf-1T3 Oes Cystofiberscope/nephrofiberscope Accessories and Ancillary Equipment | Olympus Optical Co., Ltd. | FAJ | Class II | |
| K993019 | Pacific Surgical Patties | V. Mueller Neuro/Spine | HBA | Class II | |
| K984360 | Colorado II Spinal System | Sofamor Danek USA,Inc. | MNH | Class II | |
| K000717 | Smith & Nephew Suturelok, Model 7207321 | Smith & Nephew, Inc. | OCW | Class II | |
| K000697 | Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits | Medtronic, Inc. | BZE | Class II | |
| K000591 | Dimension Penta H, Dimension Penta H Quick | Espe Dental AG | ELW | Class II | |
| K000588 | Dimension Garant L, Dimension Garant L Quick | Espe Dental AG | ELW | Class II | |
| K000369 | Vacuflow+ Blood Collection Set, Model 52221/3/5; Vacuflow+ with Holder Blood Collection Set, Model 82021/3/5 with Holder | Medpro Technologies, Inc. | FMI | Class II | |
| K000046 | Knight Endoscopic Spine System (Kess) | Richard Wolf Medical Instruments Corp. | HRX | Class II | |
| K000037 | Monofilament Biosyn Suture | United States Surgical, A Division of Tyco Healthc | GAM | Class II | |
| K000032 | Leveen Needle Electrode | Radiotherapeutics Corp. | GEI | Class II | |
| K000018 | Branemark Novum | Nobel Biocare Uas, Inc. | DZE | Class II | |
| K994026 | Eub-6000 Ultrasound Diagnostic Scanner | Hitachi Medical Corp. of America | IYN | Class II | |
| K993201 | Health-Plus, Sanitex, Reliance Poweder-Free Sterile Latex Surgical Gloves | Pamitex Industries Sdn Bhd | KGO | Class I | |
| K992554 | Synthetic Powdered Vinyl Patient Examination Gloves | Shijiazhuang Great Vision Plastic Products Co., LT | LYZ | Class I | |
| K992215 | Multicompatible Envitec Finger Clip Sensor, Multicompatible Envitec Adult Disposable Sensor, Multicompatible Envitec Ped | Envitec-Wismar GmbH | DQA | Class II | |
| K000742 | Synthes Anterior Cslp System | Synthes GmbH | KWQ | Class II | |
| K000677 | Zuma Guide Catheters | Medtronic, Inc. | DQY | Class II | |
| K000671 | Powdered Latex Exam Gloves, Pink, With/without Strawberry Scent, Protein Labeling | Sgmp Co., Ltd. | LYY | Class I | |
| K000659 | Modification to Softouch Diagnostic Intravascular Cat | Merit Medical Systems, Inc. | DQO | Class II | |
| K000648 | Spiro Pro | Erich Jaeger, Inc. | BTY | Class II |