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 |
|---|---|---|---|---|---|
| K890615 | Directigen1-2-3 Bhcg Pregnancy Test | Ortho-Clinical Diagnostics, Inc. | JHI | Class II | |
| K890491 | Cell-Dyn 3000 Multi-Parameter Hematology Analyer | Abbott Diagnostics | GKZ | Class II | |
| K890053 | Mardx Lyme Disease Igg Ifa Test System | Mardx Diagnostics, Inc. | LSR | Class II | |
| K884913 | Merit Intelliflator(tm) & Merit Monitor(tm) | Merit Medical Systems, Inc. | DXT | Class II | |
| K884206 | Hemawipe System, the Civilized Test | Labeltape Meditect, Inc. | KHE | Class II | |
| K891921 | Bicarbonate Concentrate Powder | Haemolyte, Inc. | KPO | Class II | |
| K891618 | Titanium Forceps | Implant Innovations International, Inc. | DZE | Class II | |
| K891615 | Surgical Drills | Implant Innovations International, Inc. | DZE | Class II | |
| K891460 | Non-Absorb Gauze Surg Sponge & Wound Dress/ext Use | Smith & Nephew United, Inc. | EFQ | Unclassified | |
| K891390 | Gk Alloy | China Link, Inc. | EJJ | Class II | |
| K891354 | Orthodontic Cotton Roll Holders | American Orthodontics | KHR | Class I | |
| K891266 | Neurofocal Collimator | Siemens Gammasonics, Inc. | KPS | Class II | |
| K891119 | T.r.s.: Tooth Replacement System | Health Technology of America, Inc. | EGG | Class I | |
| K891101 | Non-Absorbable Gauze, Surgical Sponge & Dressing | Smith & Nephew United, Inc. | NAB | Class I | |
| K890940 | Modified Labeling for Polyderm Wbc(tm) | Laivan Corp. | NAD | Class I | |
| K890850 | Century Disosable Latex Glove | Century Force Co., Ltd. | LYY | Class I | |
| K890829 | Unifast Lc | G-C Intl. Corp. | EBG | Class II | |
| K890729 | Suture Removal Kit | Cypress Medical Products LLC | LRO | Class II | |
| K890668 | Clean Dent | Lincoln Park Dental Laboratory | EFT | Class I | |
| K890656 | Lip Bumper | American Orthodontics | EJF | Class I | |
| K890623 | Fluorever(r) Dual Cure Ceramic Veneer Cement | Macrochem Corp. | EMA | Class II | |
| K890608 | Fluorever(r) Light Cure Ceramic Veneer Cement | Macrochem Corp. | EMA | Class II | |
| K890595 | Mentor Anterior Segment Vitrector | Mentor O & O, Inc. | HKP | Class II | |
| K890306 | Bcm-Arc 105 X-Ray Mobile Unit | B C Medical, Ltd. | IZL | Class II | |
| K890300 | Intercassette, Interkit, Universal Pak & Cassette | CooperVision, Inc. | HQE | Class II | |
| K890029 | Hemo-Cath Silicone Double Lumen Catheter | Medical Components, Inc. | LFJ | Class II | |
| K885325 | Frastec Conformant Dressing, Various Sizes | Frastec Wound Care Products, Inc. | NAD | Class I | |
| K884675 | Apex 609R Anger Camera | Elscint, Inc. | IYX | Class I | |
| K884674 | Apex 415 Anger Camera | Elscint, Inc. | IYX | Class I | |
| K884672 | Apex 115 Nuclear Medicine Processor | Elscint, Inc. | IYX | Class I | |
| K884166 | Dicor Ceramic Inlay - New Technic | Dentsply Intl. | ELW | Class II | |
| K884097 | Morris Anti-Splatter Device for Endoscopes | Circon Acmi | ODC | Class II | |
| K882572 | Doctor Kolynos Toothbrush | Whitehall Laboratories, Inc. | EFW | Class I | |
| K892146 | C Reactive Protein Liquid | Ampcor, Inc. | DCK | Class II | |
| K892129 | Ez Complement C4 | Diamedix Corp. | DBI | Class II | |
| K892127 | Ez Complement C3 | Diamedix Corp. | CZW | Class II | |
| K892125 | Ez Complement C2 | Diamedix Corp. | CZW | Class II | |
| K892119 | Quik-Dot C Reactive Protein | Ampcor, Inc. | DCK | Class II | |
| K891904 | Ez Complement C1 | Diamedix Corp. | DAC | Class II | |
| K891740 | Patient Exam Gloves (Latex) Mfg. Tianjin Kang Bao | Brilliant Ray Intl., Inc. | LYY | Class I | |
| K891739 | Patient Exam Glove (Latex) Mfg. Tianjin Ji County | Brilliant Ray Intl., Inc. | LYY | Class I | |
| K891637 | Patient Examination Gloves (Latex) | Powercrest (M) Sdn. Bhd. | LYY | Class I | |
| K891636 | Patient Examination Gloves (Latex) | Broadland Rubber Industries Sdn Bhd | LYY | Class I | |
| K891530 | M-77 Gold Base Dental Alloy | Macdonald Metals and Ceramics | EJT | Class II | |
| K891516 | C-89 Gold Base Dental Alloy | Macdonald Metals and Ceramics | EJT | Class II | |
| K891484 | Orthodontic Wrap-Around Hawley Retainer | American Orthodontics | EJF | Class I | |
| K891377 | Hilaris-Nori Cervix Applicator | Mick Radio-Nuclear Instruments, Inc. | IWJ | Class I | |
| K891215 | Fast Wrap #M 101 | Pro-Safe Professional Linens, Inc. | KCT | Class II | |
| K891214 | Dental Surgical Wrap #3007 A,b,c | Pro-Safe Professional Linens, Inc. | KCT | Class II | |
| K891213 | Surgical Instrument Pouch #M102 | Pro-Safe Professional Linens, Inc. | KCT | Class II |