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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K211256 | Disposable Sampler Viral Transport Media | Wuxi Nest Biotechnology Co., Ltd | JSM | Class I | |
| K210545 | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine | Marci Beauty LLC | OLP | Class II | |
| K221232 | Univers Revers Humeral Cup Implant | Arthrex GmbH | HSD | Class II | |
| K221135 | X-Twist PEEK Suture Anchor | Parcus Medical, L.L.C. | MBI | Class II | |
| K221134 | Procedure Mask with Ear Loops and Surgical Mask with Ties | Safesource Direct | FXX | Class II | |
| K220849 | Accu-Chek Safe-T-Pro Plus Lancing Device | Roche Diabetes Care, Inc. | FMK | Class II | |
| K220824 | Medical Surgical Mask (Planar type) | Hunan Chopard Medical Devices Co., Ltd. | FXX | Class II | |
| K220792 | SMR Reverse Liner | Lima Corporate S.p.A. | MBF | Class II | |
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | The Anspach Effort, Inc. | HBC | Class II | |
| K220423 | PAPAYA & PAPAYA Plus | Genoray Co., Ltd. | MUH | Class II | |
| K220392 | PAPAYA 3D & PAPAYA 3D Plus | Genoray Co., Ltd. | OAS | Class II | |
| K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | |
| K220285 | PINE Pedicle Screw System | Tdm Co., Ltd. | NKB | Class II | |
| K213800 | Artiglass NRFitTM Tip L.O.R. Glass Syringes | Artiglass SRL | QEH | Class II | |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | PIF | Class II | |
| K212565 | CoverScan v1 | Perspectum Ltd. | LLZ | Class II | |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi ve | LOD | Class II | |
| K211534 | RevoLix HTL | Lisa Laser Products GmbH | GEX | Class II | |
| K210983 | BD Epilor Syringe | Becton Dickinson & Co | CAZ | Class II | |
| K210596 | ARCHITECT Toxo IgG | Abbott Medical | LGD | Class II | |
| K202525 | Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division | MMI | Class II | |
| K220917 | gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler | GRI-Alleset, Inc. | FMK | Class II | |
| K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | LPH | Class II | |
| K220467 | The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories | Lumenis Ltd | GEX | Class II | |
| K220463 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | HRS | Class II | |
| K220333 | Medline Orbis LVL 3 Surgical Gown | MEDLINE INDUSTRIES, LP - Northfield | FYA | Class II | |
| K220218 | Siren SGT | Tools for Surgery, LLC | KNT | Class II | |
| K220211 | Nitrile Powder Free Examination Gloves | Hebei Kangxida Medical Technology Development Co., Ltd. | LZA | Class I | |
| K214120 | GSS610N21 Series Steam Sterilizer | Maquet Cardiovascular Us Sales, LLC | FLE | Class II | |
| K213840 | MolecuLight I:X | Moleculight Corp | QJF | Class II | |
| K212416 | WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 | Wenzhou Xikang Medical Instruments Co., Ltd. | DXQ | Class II | |
| K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) | P.T. Maja Agung Latexindo | LZA | Class I | |
| DEN210046 | Quell-FM | Neurometrix, Inc. | QSQ | Class II | |
| K221240 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K221219 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K220919 | MULTIX Impact E | Siemens Medical Solutions USA, Inc. | KPR | Class II | |
| K220807 | Imperative Care Radial 088 Access System | Imperative Care Inc. | QJP | Class II | |
| K220516 | CATALYS Precision Laser system | Advanced Medical Optics, Inc. | OOE | Class II | |
| K220499 | Rapid PE Triage and Notification (PETN) | Ischemaview, Inc. | QAS | Class II | |
| K220372 | Heel Stick Safety Lancet (HHZ-II, HHZ-III) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | |
| K220194 | Procedure mask/Surgical mask/Face mask | Winner Medical Co., Ltd. | FXX | Class II | |
| K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO, Ltd. | OHS | Class II | |
| K213787 | Monaco RTP System | Elekta Solutions AB | MUJ | Class II | |
| K212782 | SternaLock Sternal Closure System | Biomet Microfixation | HRS | Class II | |
| K212761 | Biocore9 Acetabular Cup System | BIOCORE9 LLC | LPH | Class II | |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | 4Web Medical, Inc. | KWQ | Class II | |
| K211396 | Neoss Individual Prosthetics | Neoss, Ltd. | NHA | Class II | |
| K210548 | Medline Integrated Arterial Catheter | Centurion Medical Products, LP | DQX | Class II | |
| DEN210044 | Cerament G | Bonesupport Inc | QRR | Class II | |
| K220669 | IPL HAIR REMOVAL HANDSET, Model: IPL-666 | Shenzhen Junbobeauty Technology Co., Ltd. | OHT | Class II |