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 |
|---|---|---|---|---|---|
| K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and Accessories | Erbe USA Inc | GEI | Class II | |
| K963183 | Bioz System | Cardiodynamics International Corp. | DSB | Class II | |
| K962816 | Sperm Preparation Media | <Genx> Intl., Inc. | MOL | Class II | |
| K962631 | Dexis Model 601 Dental Electronic Imaging System | Fair Image, Inc. | EHD | Class II | |
| K962623 | Osmocyte Ultra/pe Pillow Wound Dressing | Procyte Corp. | KMF | Class I | |
| K962205 | Sterile and Non-Sterile o.r. Towels, Sterile and Non-Sterile X-Ray Detectable o.r. Towels, Single Use | MEDLINE INDUSTRIES, LP - Northfield | KKX | Class II | |
| K962045 | Anesthesia Breathing Circuit/anesthesia Breathing Kit | Mallinckrodt Medical | CAH | Class II | |
| K961656 | Test-Mate Che Cholinesterase Test System | Eqm Research, Inc. | DIH | Class I | |
| K955756 | Karl Storz Point Coagulator, Semm Crocodile Forceps, Myoma Enucleator | Karl Storz Endoscopy-America, Inc. | HGI | Class II | |
| K953252 | Disposable Scalp Vein Infusion Set | Myco Medical Supplies Inc | FOZ | Class II | |
| K964422 | Ontrak Testtcup Collection/urinalysis Panel | Roche Diagnostic Systems, Inc. | DIF | Class I | |
| K964413 | Sunglasses(non-Prescription) | Ever Prime Enterprises, Ltd. | HQY | Class I | |
| K964213 | Trace Rite Solid Gel ECG Electrodes | ZOLL Medical Corporation | DRX | Class II | |
| K964156 | Contrast Strip Hcg | Sekisui Diagnostics, LLC | JHI | Class II | |
| K964155 | Contrast Hcg Urine/serum Test and Rapid Hcg Urine/serum Test | Sekisui Diagnostics, LLC | JHI | Class II | |
| K964087 | Block Stop Wires | Ferguson Medical | HTY | Class II | |
| K964082 | Sunglasses | Neo Vu, Inc. | HQY | Class I | |
| K964058 | Spenser Sunglasses and Sport Sunglasses | Spencer Products Co. | HQY | Class I | |
| K964011 | Suction Catheter Tray Product No. 900277 | Customed, Inc | LRO | Class II | |
| K963954 | Cd 19 R-Pe, Cd19 Tri-Color Monoclonal Antibody | Caltag Laboratories, Inc. | GKZ | Class II | |
| K963783 | Mitek Electrosurgical System for Arthroscopic Use | Ethicon, Inc | GEI | Class II | |
| K963768 | Instant Hot Packs | Kick Ice, Inc. | IMD | Class I | |
| K963686 | Anspach Suture Anchor (Modified) | The Anspach Effort, Inc. | MBI | Class II | |
| K963434 | Viscous Fluid System | Escalon Trek Medical | MRH | Class II | |
| K963415 | Ventrex Oxygen Sensor | Ventrex, Inc. | CCL | Class II | |
| K963397 | Ultra-Thin Diamond Balloon Dilatation Catheter | Boston Scientific Corporation | FGE | Class II | |
| K962568 | Acri Iliac Crest Aspiration Biopsy Needles | Gallini Intl., Inc. | FCG | Class II | |
| K962452 | Hy-Tec/manual Autoimmune Kit for Mitochondria | Hycor Biomedical | DBM | Class II | |
| K962451 | Hy-Tec/manual Autoimmune Kit for Thyroid Microsomal (Tpo) | Hycor Biomedical | JNL | Class II | |
| K962450 | Hy-Tec/manual Autoimmune Kit for Histone | Hycor Biomedical | LJM | Class II | |
| K962341 | Hy-Tec/manual Autoimmune Kit for Thyroglobulin (Tg) | Hycor Biomedical | JNL | Class II | |
| K962252 | Health O Meter Electric Heating Pad W/massage Model Ehp4 | Sunbeam Health Division | IRT | Class II | |
| K962157 | Model 1310 Neurolink Neuromonitoring System | Physiometrix, Inc. | GWQ | Class II | |
| K962019 | C-Reactive Protein (Crp):a Latex Slide Test | Teco Diagnostics | DCK | Class II | |
| K962015 | Rheumatoid Factor (RF) Reagenti a Latex Slide Test | Teco Diagnostics | DHR | Class II | |
| K961738 | Vit Commander System | Scieran Technologies, Inc. | HQE | Class II | |
| K960615 | Gauze Compress | Certified Safety Mfg Inc | EFQ | Unclassified | |
| K964565 | Paramax Ammonia and Ammonia Blank Reagent | Dade Intl., Inc. | JIF | Class I | |
| K964278 | Whole Blood Glucose Control Level 1,2,And 3/Whole Blood Glucose Linearity Control-Level1,2,3,4,5,and 6 | Clinical Controls, Inc. | JJX | Class I | |
| K963778 | Cdr-Cam | Schick Technologies, Inc. | EIA | Class I | |
| K963750 | Retrieval Snare | Boston Scientific Corporation | FGO | Class II | |
| K963564 | Personal Limb Holder (24444-200,300,24444-Kit) | Tecnol Medical Products, Inc. | FMQ | Class I | |
| K963559 | Wrparound Limb Holder (24446,24446-350,24447-010,24449-010) | Tecnol Medical Products, Inc. | FMQ | Class I | |
| K963552 | Quick Release Limb Holder (24442,24442-050,24442-350) | Tecnol Medical Products, Inc. | FMQ | Class I | |
| K963485 | Silicone Rubber Cuff/disposable Fleece Liner's Web Torso Resraint,nyon Limb Holder,vinyl Limb Holder,nylon Bed Restrains | Humane Restraint Co., Inc. | FMQ | Class I | |
| K963442 | Jackets and Vests | J. T. Posey Co. | FMQ | Class I | |
| K963436 | Restraint Accessories | J. T. Posey Co. | FMQ | Class I | |
| K963430 | Protective Restraint (Vest Restraint) | Kenad SG Medical, Inc. | FMQ | Class I | |
| K963422 | Protective Restraint (Protective Mitt) | Kenad SG Medical, Inc. | FMQ | Class I | |
| K963421 | Protective Restraint (Waist Holder) | Kenad SG Medical, Inc. | FMQ | Class I |