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 |
|---|---|---|---|---|---|
| K092461 | Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140 | United States Endoscopy Group, Inc. | OCX | Class II | |
| K092440 | Ascension Cannulated Screw System | Ascension Orthopedics, Inc. | HWC | Class II | |
| K092298 | Modification to Modified Hd Guide Catheter | Concentric Medical, Inc. | DQY | Class II | |
| K092133 | Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065N | ArthroCare Corporation | HWC | Class II | |
| K091568 | Lh-75 Phototherapy System | Lerner Medical Devices, Inc. | FTC | Class II | |
| K091367 | Gds-Dcs | Guided Delivery Systems | DYB | Class II | |
| K091309 | Revolution Femoral Intramedullary Nail System, Model Dgooxx | Dgimed Ortho, Inc. | HSB | Class II | |
| K090804 | Nasal Aire II Pediatric, Model 5 Sizes, Model Tbd | Innomed Technologies, Inc./Respcare, Inc. | BZD | Class II | |
| K082399 | Pectus Strut | Koros USA, Inc. | HRS | Class II | |
| K093276 | Powder-Free Vinyl Patient Examination Gloves | Tangshan Kangyuan Glove Co., Ltd. | LYZ | Class I | |
| K093270 | Powder-Free Vinyl Patient Examination Gloves | Tangshan Excellence Glove Co., Ltd. | LYZ | Class I | |
| K093170 | Romeo Posterior Osteosynthesis System | Spineart SA | MNI | Class II | |
| K093130 | Engage Tr Introducer | Abbott Medical | DYB | Class II | |
| K092657 | Epifuse Catheter Connector, Model: 4909E | Abbott Medical | CAZ | Class II | |
| K092563 | Gator Clipseal Plug | Vascular Solutions LLC | DTL | Class II | |
| K092490 | Amsco Evolution Series Steam Sterilizer, Model: Hc-2000 and Hc-3000 | STERIS Corporation | FLE | Class II | |
| K092406 | Abg II Modular Hip Stem | Howmedica Osteonics Corp | MEH | Class II | |
| K092384 | Liquicord | Centrix, Inc. | MVL | Unclassified | |
| K092313 | Perfusor Space Infusion Syringe Pump System | B.Braun Medical, Inc. | MEA | Class II | |
| K092072 | Powder Free Nitrile Examination Glove, Grape Scented, Blue | Gx Corporation Sdn Bhd | LZA | Class I | |
| K091750 | Guideliner Catheter, Models 5571, 5572, 5573 | Vascular Solutions LLC | DQY | Class II | |
| K092822 | Capri Applicator | Vivaray, Inc. | JAQ | Class II | |
| K092446 | Intra Lux Head 3 Ldsy | Kaltenbach & Voigt GmbH | EFA | Class I | |
| K092386 | R3 Multi-Hole Shells and 36Mm Xlpe Acetabular Liners | Smith & Nephew, Inc. | MBL | Class II | |
| K092377 | Plastic Temporary Abutments, Models: Pt341s, Pt344s, Pt341a, Pt344a, Pt451s, Pt454s, Pt451a, Pt454a, Pt561s, Pt564s | ZimVie US Corp LLC | NHA | Class II | |
| K092368 | Reprocessed Pulse Oximeter Sensors | Sterilmed Inc | NLF | Class II | |
| K092364 | Model 220 Patient Magnet | LivaNova USA, Inc. | DTG | Class I | |
| K092320 | Elecsys Precicontrol Thyroab | Roche Diagnostics GmbH | JJY | Class I | |
| K091927 | Intellivue Patient Monitors ,Models Mp40, Mp50, Mp60, Mp70, Mp80, Mp90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac an | DSI | Class II | |
| K091625 | Epicare-Duo Laser System | Light Age, Inc. | GEX | Class II | |
| K092790 | Powder-Free Vinyl Patient Examination Gloves | Zibo Boxiang Plastic & Rubber Co., Ltd. | LYZ | Class I | |
| K092378 | Spectranetics Visisheath Dilator Sheath | Spectranetics Corp. | DRE | Class II | |
| K092362 | Sleepweaver Nasal CPAP Mask | Circadiance | BZD | Class II | |
| K092359 | Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-Hd-19A | Cook Ireland Ltd. | FCG | Class II | |
| K092317 | Deroyal Non-Sterile Locking Compression Plate System | DeRoyal Industries, Inc. | HRS | Class II | |
| K092167 | Kimguard One-Step Sterilization Wrap, Models Kc100, Kc200, Kc300, Kc400, Kc500, Kc600 | Kimberly-Clark Corporation | FRG | Class II | |
| K091743 | Sec Vbr | Innvotec Surgical, Inc. | MQP | Class II | |
| K091653 | Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control, Models 5024-0001-00, 5024-0002-00 | Ark Diagnostics Inc | ORI | Class II | |
| K091643 | Powder Free Latex Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs | Gx Corporation Sdn Bhd | LZC | Class I | |
| K091607 | Alpha-Bsm, Beta-Bsm, Gamma-Bsm, Equivabone | Etex Corp. | MQV | Class II | |
| K091531 | Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer | Choice Spine LLC | ODP | Class II | |
| K091192 | Kensey Nash P1076 Collagen Dental Membrane, Model 20655-Xx | DSM Biomedical, Inc. | NPL | Class II | |
| K082534 | Etest Voriconazole 0.002-32 Ug/ml | Ab Biomerieux | NGZ | Class II | |
| K093300 | Esteem Smt Polyisoprene Powder-Free Surgical Sterile Gloves | Medtronic, Inc. | KGO | Class I | |
| K093234 | Integrated Registration | GE Medical Systems SCS | LLZ | Class II | |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension II | Dentsply Intl. | DYH | Class II | |
| K092717 | Direct Digitizer, Regius Model 210 | Konica Minolta Medical & Graphic, Inc. | MQB | Class II | |
| K092623 | F.a.s.t. System Sed and Cxd | Genesis Medical Interventional, Inc. | QEW | Class II | |
| K092585 | Elecsys Rubella Igga Calcheck 5 | Roche Diagnostics GmbH | JJX | Class I | |
| K092581 | Mits Dicom Gateway and Image Manager | Mitsmed Medical Instrument Technology Co., Ltd. | LLZ | Class II |