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 |
|---|---|---|---|---|---|
| K930913 | Coulter Mh015 (Differential Cell Counter) | Coulter Corp. | GKZ | Class II | |
| K930282 | Aviva F22/mam-Ch22 W/optional Cytoguide Biopsy Sys | Elscint, Inc. | IZH | Class II | |
| K930198 | Lens, Spectacle, Non-Custom (Prescription) | Forda (China) Optical Co. | HQY | Class I | |
| K930104 | Ace Clinical Chemistry System | Schiapparelli Biosystems, Inc. | JIX | Class II | |
| K925524 | Cardiometrics Smartwire(tm)/flomap(r) | Cardio Metrics, Inc. | DPW | Class II | |
| K925040 | Telepulse | Biometrix Ltd. | JEH | Class II | |
| K924737 | Innersense(tm) Disposable Microtransducer | Becton Dickinson Vascular Access, Inc. | DXO | Class II | |
| K932147 | Non Conductive Anesthesia Face Mask,silicone | Hans Rudolph, Inc. | BSJ | Class I | |
| K931991 | Gnomos Stereotactic System W/ Noninvasive Fixation | Nomos Corp. | HAW | Class II | |
| K931952 | Medway Oxygen Mask | Medway | BYG | Class I | |
| K931645 | Halux Tasklight | Burton Medical Products Corp. | KZF | Class I | |
| K931619 | Microvasive Extractor, Retrieval Balloon Catheter | Boston Scientific Corporation | GCA | Class II | |
| K931132 | Cadd-Micro(tm) Model 5900 Ambulatory Infusion Pump | Pharmacia Deltec, Inc. | FRN | Class II | |
| K931115 | Hatcher Stone-Embolis Extractor | Ideal Medical, Inc. | LQR | Class II | |
| K930748 | Sigma Mp Multiplace Hyperbaric Chamber | Perry Baromedical Services | CBF | Class II | |
| K925952 | Medtronic Model 3990 Pns Lead | Medtronic, Inc. | GZF | Class II | |
| K925947 | B-D Arterial Blood Containment Device | BD Becton Dickinson Vacutainer Systems Preanalytic | DQX | Class II | |
| K933373 | Ciba Corning 300 Series System | Ciba Corning Diagnostics Corp. | JGS | Class II | |
| K933310 | Micrins Contrast Background Material | Micrins Surgical, Inc. | EPT | Class I | |
| K932703 | Beltone Prima 2000 | Beltone Electronics Corp. | ESD | Class I | |
| K932674 | Clinitek Atlas Automated Urine Chemistry System | Miles Inc., Dental Products | KQO | Class I | |
| K932610 | Pci 4000 | Pci | IPF | Class II | |
| K932555 | Dc-Lineate Cat. No. Se-091 | Diagnostic Chemicals, Ltd. (USA) | JIS | Class II | |
| K932534 | Isi Fenestrated Dissecting and Grasping Forceps | Innovative Surgical, Inc. | GFI | Class I | |
| K932520 | Calibration Gas | Cryodyne Technologies, Inc. | BXK | Class I | |
| K931878 | Jarit Endoscopes, 600-600; 600-630; 600-650; 680 | J. Jamner Surgical Instruments, Inc. | GCJ | Class II | |
| K931745 | Olympus Reply Urea Nitrogen Reagent | Olympus Corp. | CDQ | Class II | |
| K931646 | Mi-4 Variable Spot Light | Medical Illumination, Inc. | KZF | Class I | |
| K931583 | Silyl Amyl | Em Diagnostic Systems, Inc. | JFJ | Class II | |
| K931582 | Ethylidene Amyl | Em Diagnostic Systems, Inc. | JFJ | Class II | |
| K931499 | Q-11 Ophthalmic Laser | Hgm, Inc. | GEX | Class II | |
| K931026 | Mi-5 Diagnostic Light | Medical Illumination, Inc. | KZF | Class I | |
| K930975 | Derma-Lase Dla-1 Laser | Derma-Lase Co. | GEX | Class II | |
| K930823 | Protein-Bound Glucose Assayn Kit | Diagnostic Specialties | LCP | Class II | |
| K930793 | Multiline; Dly-1 | Derma-Lase Co. | GEX | Class II | |
| K930781 | Infusion Pump | Y | FRN | Class II | |
| K930514 | Surgic-Alert Monitor | Novatec Medical Products, Inc.--Glove Monitor | LDQ | ||
| K930305 | Cobas Core Prolactin Eia | Roche Diagnostic Systems, Inc. | CFT | Class I | |
| K930050 | Sia Thyroid Stimulating Hormone Elisa Kit | Sigma Chemical Co. | JLW | Class II | |
| K926435 | Comfortade | Sensible Products | FNL | Class II | |
| K925625 | Omni | Bio-Tek Instruments, Inc. | JJQ | Class I | |
| K925244 | Sensicare Powder Free Medical Glove | BD Becton Dickinson Vacutainer Systems Preanalytic | LYZ | Class I | |
| K924558 | Arrow Blood Containment Device | Arrow Intl., Inc. | DQX | Class II | |
| K923026 | Pikos 01-a and Pikos E01-a Implantable Pacemaker | BIOTRONIK AG | DXY | Class III | |
| K922618 | Bowron | G.L. Bowron & Co., Ltd. | FMZ | Class II | |
| K932998 | Easy-on | Devon Industries, Inc. | GES | Class I | |
| K932917 | Pasco Mic and Mic/id Panels | Pasco Laboratories, Inc. | JWY | Class II | |
| K932229 | Surgical Trocar and Trocar Sleeve | Origin Medsystems, Inc. | GCJ | Class II | |
| K931518 | Imagyn Medical Videoscopy Syst W/irrig Pump & Acce | Imagyn Medical, Inc. | GCJ | Class II | |
| K926438 | Action Medtek Face Shield | Action Eyewear Corp. | LYU | Class I |