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 |
|---|---|---|---|---|---|
| K001584 | Metrofocal Toric (Hioxifilcon a) Soft (Multifocal) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-Cut | Medvice Consulting, Inc. | LPL | Class II | |
| K001485 | Health-Plus, Sanitex, Reliance, Powder-Free Latex Examination Gloves | Pwa Industries Sdn. Bhd. | LYY | Class I | |
| K001475 | Health-Plus, Sanitex, Reliance, Powdered Latex Exam Gloves Contains 100 Micrograms or Less of Total Water Extractable Pr | Pwa Industries Sdn. Bhd. | LYY | Class I | |
| K001326 | Natural-Iris Pre-Pigmented Corneal Button | Ocular Concepts, LLC | NCK | Class I | |
| K001309 | Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material, Model 98250 | Kay See Dental Mfg. Co. | EBG | Class II | |
| K001113 | Ivc Three Blastocyst Medium, Cat # 2007 | Invitrocare Inc | MQL | Class II | |
| K001012 | Digital Integration System, Dis2000 | Wellington Medical Systems, Inc. | LLZ | Class II | |
| K000981 | Ceramix Ez Cast, Ceramix Ez Cast Solder, Ceramix Ez Cast Flux | C-Mix | EJH | Class II | |
| K000627 | Scandinavian Ivf Sciences Ab, Hybase-1 | Vitrolife AB/Scandinavian Ivf Sciences AB | MQL | Class II | |
| K000237 | Ehc 400 Desktop Patient Station, Ehc 600 Core Provider Station | Cybercare, Inc. | DXN | Class II | |
| K993518 | Medefil's Heparin i.v. Flush Syringe, in Various Fill Sizes - 1 Ml Fill in 3 Ml Syringe Ll; 1 Ml Fill in 6 Ml Syringe Ll | Medefil, Inc. | FOZ | Class II | |
| K993335 | Synthes Reamer/irrigator/aspirator (Ria) System | Synthes (USA) Products LLC | HTO | Class I | |
| K001594 | 3.5 Mm Laparoscope (Lg100, Lg103) | Surgical Image Laboratories, Inc. | GCJ | Class II | |
| K001549 | Multiple Private Labels, Nitrile Exam Gloves, Powder-Free (White) | Shanghai Poseidon Plastic Products Co., Ltd. | LZA | Class I | |
| K001534 | Pinnacle Acetabular System | Depuy Orthopaedics Inc. | LPH | Class II | |
| K001529 | Polymer Coated, Powder-Free Latex Examination Glove with Protein Labelling Claim, Contains 50 Micrograms or Less of Tota | Perusahaan Getah Asas Sdn. Bhd. | LYY | Class I | |
| K001434 | 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture | Genzyme Surgical Product (Genzyme Biosurgery) | GAT | Class II | |
| K001343 | Eudermic Pf Powder-Free Surgical Gloves | Maxxim Medical | KGO | Class I | |
| K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Navigation, Inc | HAW | Class II | |
| K001252 | Maxhealth Wheelchair, Model He-8631, He-8621, He-8651 | Maxhealth Corp. | IOR | Class I | |
| K000687 | The Daya Syphilis Test/the Trust Antigen Test | Beacon Biologicals, Inc. | GMQ | Class II | |
| K000072 | Dornier Medilas D Skinpulse | Dornier Surgical Products, Inc. | GEX | Class II | |
| K994199 | Various Sterile and Non-Sterile Surgical Drapes, (I.e., Disposables Minor Procedure Drapes, Large Aperture Drapes, Absor | Custom Medical Products, Ltd. | KKX | Class II | |
| K993701 | Pharmaseed, Model Bt-125-2 | Syncor International, Inc. | KXK | Class II | |
| K993697 | Delfia Neonatal Irt Kit | Wallac Oy | CGZ | Class II | |
| K993653 | Micro-France Trocars and Accessories | Xomed, Inc. | HET | Class II | |
| K993316 | Ueda Udex Super Bp-2000 Automatic Blood Pressure Recording Device | Ueda Avancer Corp. | DXN | Class II | |
| K001574 | Diastat Anti-Cardiolipin Igg/igm, Model Fcar 600 | Axis-Shield, Ltd. | MID | Class II | |
| K001557 | Laxtex Powdered Examination Glove with Protein Labeling Claim (100 Micrograms or Less) | Kossan Latex Industries (M) Sdn Bhd | LYY | Class I | |
| K001488 | Narkomed MRI , Nm-MRI | Draeger, Inc. | BSZ | Class II | |
| K001474 | Terumo U-100 Insulin Syring | Terumo Medical Corp. | FMF | Class II | |
| K001331 | Synergy Head/neck Coil | Philips North America LLC | MOS | Class II | |
| K001287 | Empty Reservoir Bag, 50 Ml,100 Ml,250 Ml,500 Ml, 1000M Ml, 1500 Ml, 2000 Ml, 3000 Ml | Sorenson Medical, Inc. | KPE | Class II | |
| K001210 | Hi-Res 9000 Phased Array Carotid Coil | GE Healthcare Coils | MOS | Class II | |
| K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corporation | DJG | Class II | |
| K001114 | 3M Quik Temp Temporization Material | 3M Company | EBG | Class II | |
| K001034 | Model Aps Alternans Processing System | Cambridge Heart, Inc. | DPS | Class II | |
| K000377 | Masif Powder-Free Patient Examination Gloves | Masif Healthcare Products Sdn. Bhd. | LYY | Class I | |
| K000358 | Multi Adjustable Face Mask | Ortho Technology | DZB | Class II | |
| K000336 | Rhigene Dsg-1 & Dsg-3 Elisa Test System, Model 7680 E | Rhigene, Inc. | NBO | Class II | |
| K994074 | Tri-Ball | Leventon, S.A. | BWF | Class II | |
| K992980 | Engage Jaw Inserts | Novare Surgical Systems, Inc. | DXC | Class II | |
| K991137 | Enguard Phx Cardioplegia Heat Exchanger | Medivators Inc | DTR | Class II | |
| K001602 | Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation (Ph. I.s.i.o.) | Dideco S.p.A. | DTN | Class II | |
| K001546 | Allon 2001 | Mtre Advanced Technology, Ltd. | DWJ | Class II | |
| K001377 | Spermicidal Lubricated Male Latex Condom | Pleasure Latex Products Sdn. Bhd. | LTZ | Class II | |
| K001313 | Airdent II Cs | Air Technologies, Inc. | KOJ | Class II | |
| K001261 | L720 Examination Chair | Luneau Gynecologie SA | KNC | Class II | |
| K001046 | Biopro Glenoid Component W/ Keel & W/ Posts | Biopro, Inc. | KWS | Class II | |
| K000989 | Sperm Wash Medium, Cat# 2003/2005 | Invitrocare Inc | MQL | Class II |