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 |
|---|---|---|---|---|---|
| K992855 | Xps Straightshot or Model 2000 Microdebrider System or Xps Powersculpt | Xomed, Inc. | QPB | Class II | |
| K992403 | Mrp-Titan | Rotec Medizintechnik GmbH | LZO | Class II | |
| K992286 | Dermafreeze | Rhealm Pharmaceuticals, Inc. | MLY | Unclassified | |
| K994273 | Model 1000 Holmium Laser System | New Star Lasers, Inc. | GEX | Class II | |
| K994258 | Sensi-Pro Disposable Powder Free Synthetic Vinyl Patient Examination Gloves with Beige Pigment Additives | Shinemound Enterprise, Inc. | LYZ | Class I | |
| K994189 | Olympus Creatine Kinase Reagent Osr6179/6279 | Olympus Diagnostica GmbH | CGS | Class II | |
| K994173 | Stellartech Radiofrequency Generator,model 1025A-115, Stellartech Radiofrequency Generator, Model 1025A-230 | Stellartech Research Corp. | GEI | Class II | |
| K994114 | Dimension Total Iron Binding Capacity (Ibct) Calibrator | Siemens Healthcare Diagnostics Inc. | JIS | Class II | |
| K994084 | Smith & Nephew Xenon Light Sources and Accessories | Smith & Nephew, Inc. | FFS | Class II | |
| K994070 | Revelation Porous Hip Stem | Encore Orthopedics, Inc. | LPH | Class II | |
| K994066 | Mtp Disposable Trocars | Mtp Medical Technical Promotion GmbH | GCJ | Class II | |
| K994019 | Cautery Grasper/dissector | Microline Surgical, Inc | HQP | Class II | |
| K994013 | Powdered Latex Examination Gloves with Protein Content Labeling Claim (100 Micrograms or Less) | Glovco (M) Sdn. Bhd. | LYY | Class I | |
| K994005 | Syva Emit II Plus Methadone Assay, Models 9E029ul/9e129ul | Syva Co. | DJR | Class II | |
| K993865 | Green Peppermint Flavored Powdered Latex Examination Gloves | Supermax Sdn Bhd | LYY | Class I | |
| K993864 | Colored and Flavored Powder Free Latex Examination Gloves | Supermax Sdn Bhd | LYY | Class I | |
| K993827 | Ufi Gel Hard | Voco GmbH | EBI | Class II | |
| K993824 | Msas Professional | Biomeridian, Int. | GZO | Class II | |
| K993797 | Ec-7701 Fluid Warming Cabinet | Enthermics Medical Systems, Inc. | LDQ | ||
| K993736 | Exactech Acumatch Integrated Hip System M-Series Femoral Stem Component | Exactech, Inc. | LPH | Class II | |
| K993682 | MRI Equipment Cover | Image-Guided Neurologics, Inc. | LNH | Class II | |
| K993598 | Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option, Model 13205 | Vidar Systems Corp. | LMA | Class II | |
| K993587 | Hp M2376a Device Link System | Hewlett-Packard Co. | MQS | Class II | |
| K993582 | Modification to Laser-Shield II | Xomed, Inc. | BTR | Class II | |
| K993483 | Acon One Step Home Pregnancy Test Strip | Acon Laboratories, Inc. | LCX | Class II | |
| K992675 | Patient Nitrile Examination Gloves (Powdered) | Wear Safe (Malaysia) Sdn Bhd | LZA | Class I | |
| K992634 | Immulite Methamphetamine, Model Lkma1, Lkma5 | Siemens Healthcare Diagnostics Inc. | LAF | Class II | |
| K992436 | Gown Back, Model 13-403N; 13-404N; 13-405N | Techstyles | FYA | Class II | |
| K000067 | Alkaline Phosphatase Liquid Reagent-Kinetic, Models A504-150 and A504-500H | Teco Diagnostics | CJE | Class II | |
| K993869 | Inter-Os Bone Generator | Inter-Os Technologies | MQN | Class II | |
| K991545 | Watch Style Wrist Digital Blood Pressure Monitor, Model: Klock | Industrielle Entwicklung Medizintechnik und Vertri | DXQ | Class II | |
| K000030 | Sonoace 600 Diagnostic Ultrasound System | Medison America, Inc. | IYO | Class II | |
| K994437 | Cynosure Photogenica Spir | Cynosure, LLC | GEX | Class II | |
| K994427 | Cynosure M2 Dermatology Laser for Hair Removal | Cynosure, LLC | GEX | Class II | |
| K994333 | Ora-50 Electrothermal System and Accessories | Oratec Interventions, Inc. | GEI | Class II | |
| K994330 | Aspect Medical Systems EEG Sensor, Model 186-0076 | Aspect Medical Systems, Inc. | GXY | Class II | |
| K994200 | Access Hybritech Psa Qc, Model 37209 | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K994132 | Hardydisk Imipenem, 10Mcg | Hardy Diagnostics | JTN | Class II | |
| K994095 | Latex Condom | Thai Nippon Rubber Industry Co., Ltd. | HIS | Class II | |
| K994081 | Safeskin Tactylon Pf Powder-Free Surgeon's Gloves | Safeskin Corp. | KGO | Class I | |
| K994071 | Rhigene Ana Elisa Test System | Rhigene, Inc. | LJM | Class II | |
| K994040 | Phased Array Knee and Foot Coil | GE Healthcare Coils | MOS | Class II | |
| K993984 | Syva Emit II Plus Cannabinoid Assay, Models 9N029ul/9n129ul | Syva Co. | LDJ | Class II | |
| K993942 | Litesaber 2000 | Laser Dental Innovations | GEX | Class II | |
| K993928 | Wako-Igg II-Ha, Immunoglobulin Calibrator Set, Immunolobulin Standard | FUJIFILM Healthcare Americas Corporation | DEW | Class II | |
| K993920 | Ethanol-L3k Assay, Catalogue Number 273-30, 273-17 | Sekisui Diagnostics P.E.I. Inc. | DIC | Class II | |
| K993870 | Unscented Interlabial Menstrual Pad | Procter & Gamble Co. | HHD | Class I | |
| K993849 | Teh Loong Vinyl, Powder-Free, Patient Examination Glove | Longbest (Xiamen) Balls Co., Ltd. | LYZ | Class I | |
| K993847 | Teh Loong, Vinyl, Powdered, Patient Examination Gloves | Longbest (Xiamen) Balls Co., Ltd. | LYZ | Class I | |
| K993813 | Lumagem Scintillation Camera | Gamma Medica | IYX | Class I |