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 |
|---|---|---|---|---|---|
| K230143 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K230098 | Trusana™ | Myerson LLC | EBI | Class II | |
| K230010 | ADSEAL Plus | Meta Biomed Co., Ltd. | KIF | Class II | |
| K223879 | Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) | Quara S.r.l. | DTR | Class II | |
| K223435 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Medical | QBJ | Class II | |
| K222738 | Point implant system | Pointnix Co., Ltd. | DZE | Class II | |
| K222350 | Sterile Nitrile Surgical Gloves Powder Free | JR Engineering and Medical Technologies (M) Sdn Bhd | KGO | Class I | |
| K222200 | Cirrus Hd-Oct | Carl Zeiss Meditec Inc | OBO | Class II | |
| K222185 | Stratus Infusion Catheter | Intervene Inc | NPG | Class II | |
| K220763 | ALPCO Calprotectin Immunoturbidimetric Assay | Alpco | NXO | Class II | |
| K213986 | CerebralGo Plus | Yukun (Beijing) Technology Co., Ltd. | QIH | Class II | |
| K193514 | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | JIL | Class II | |
| K230424 | Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System | Omnia Medical | KWQ | Class II | |
| K223838 | Catalys™ Precision Laser System | Advanced Medical Optics, Inc. | OOE | Class II | |
| K223332 | Task Force CORE | CNSYSTEMS MEDIZINTECHNIK GmbH | DXN | Class II | |
| K220312 | Polyfusion IV Administration Sets | Poly Medicure Limited | FPA | Class II | |
| K230754 | L12 LED Light Source with AIM | Stryker Corp. | OWN | Class II | |
| K230753 | Rct800 | Ray Co., Ltd. | OAS | Class II | |
| K230732 | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | MUH | Class II | |
| K230705 | POT PTCA Balloon Dilatation Catheter | BrosMed Medical Co.,Ltd. | LOX | Class II | |
| K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | NTE | Class II | |
| K223830 | Ultrasound System 2300 | BK Medical ApS | IYN | Class II | |
| K223763 | ZeptoLink IOL Positioning System | Centricity Vision, Inc. | PUL | Class II | |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Head Quarters | NRY | Class II | |
| K222910 | Bronchoscope System | Shenzhen Hugemed Medical Technical Development Co., Ltd | EOQ | Class II | |
| K222781 | Augmento | Deeptek Medical Imaging Private Limited | LLZ | Class II | |
| K221303 | Neuspera Nuity System | Neuspera Medical, Inc. | GZF | Class II | |
| K230699 | ARIA Radiation Therapy Management (v18.0) | Varian Medical Systems, Inc. | IYE | Class II | |
| K230695 | APRO 70 Catheter and Alembic Aspiration Tubing | Alembic LLC | NRY | Class II | |
| K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | Arthrex GmbH | PHX | Class II | |
| K230360 | IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 | Shenzhen Jizhimei Technology Co., Ltd. | OHT | Class II | |
| K230164 | TENS and EMS Stimulation (OTC) | Changsha Yuwen Medical Equipment Co., Ltd. | NUH | Class II | |
| K230122 | IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K223550 | Dmx | Del Medical, Inc. | KPR | Class II | |
| K223176 | Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister | Argon Medical Devices, Inc | KRA | Class II | |
| K222887 | Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor | Famidoc Technology Co., Ltd | DXN | Class II | |
| DEN220033 | MISHA Knee System | Moximed, Inc. | QVV | Class II | |
| K230658 | SKOUT® system | Iterative Scopes, Inc. | QNP | Class II | |
| K230575 | Limbus Contour | Limbus AI | LLZ | Class II | |
| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring | Corcym Inc. | KRH | Class II | |
| K230064 | Mazor X System (Mazor X Stealth Edition) | Mazor Robotics Ltd | OLO | Class II | |
| K223816 | Dental CT Scanner AXR | Alliage S/A Industrias Medico Odontologica | OAS | Class II | |
| K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta) | Stryker Corp. | HRS | Class II | |
| K223640 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48) | Axogen Corporation | JXI | Class II | |
| K223373 | Enivo™ | AROA Biosurgery Inc. | BTA | Class II | |
| K223088 | BD SmartSite™ Needle-Free Connector | Care Fusion | FPA | Class II | |
| K223052 | Peri-Guard and Supple Peri-Guard | Synovis Life Technologies, Inc. | FTM | Class II | |
| K222909 | Axiostat Gauze | Advamedica Inc. | QSY | Unclassified | |
| K220456 | Elecsys FT4 IV | Roche Diagnostics GmbH | CEC | Class II | |
| DEN210055 | The N-SWEAT Patch | Candesant Biomedical, Inc. | QVX | Class II |