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 |
|---|---|---|---|---|---|
| K231376 | Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) | Smith & Nephew, Inc. | MBI | Class II | |
| K231167 | Conductive Silicone Rubber Electrode | Guangzhou Xinbo Electronic Co., Ltd | GXY | Class II | |
| K231164 | Conductive carbon film electrode | Guangzhou Xinbo Electronic Co., Ltd | GXY | Class II | |
| K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System | Zimmer Switzerland Manufacturing GmbH | HSB | Class II | |
| K230304 | Polyisoprene Surgical Gloves | Puyang Linshi Medical Supplies Co., Ltd. | KGO | Class I | |
| K222443 | Air Smart Extra Spirometer | Feellife Health Inc. | BZG | Class II | |
| K232100 | Efai Pacs Picture Archiving and Communication System Pro | Ever Fortune.Ai, Co., Ltd. | LLZ | Class II | |
| K232052 | Ceribell Instant EEG Headband | Ceribell, Inc. | GXY | Class II | |
| K232008 | Disposable Medical Examination Nitrile Gloves | Raxwell Industrial, LLC | LZA | Class I | |
| K231857 | Arthrex TightRope II | Arthrex GmbH | MBI | Class II | |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | DQO | Class II | |
| K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | GEH | Class II | |
| K223924 | LW Implant System | Ossvis Co., Ltd. | DZE | Class II | |
| K223633 | Rubicon™ Control Support Catheter (H749394323506A1) | Boston Scientific Corporation | DQY | Class II | |
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics Inc. | LEH | Class II | |
| K222128 | Protective Gown AAMI Level 4 | Kenpax International Limited | QPC | Class II | |
| K231501 | PRO-LITE Sterilization Tray | STERIS Corporation | KCT | Class II | |
| K231500 | Vis-U-All Low Temperature Sterilization Pouches | STERIS Corporation | FRG | Class II | |
| K231490 | Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator | STERIS Corporation | FRC | Class II | |
| K231488 | Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | STERIS Corporation | JOJ | Class II | |
| K231098 | LineSider® Spinal System | Integrity Implants, Inc. | NKB | Class II | |
| K230376 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC. | PNE | Class II | |
| K223713 | Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. | LZA | Class I | |
| K223476 | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | MLR | Class II | |
| K220828 | SQA-iO Sperm Quality Analyzer | Medical Electronic Systems Ltd. | POV | Class II | |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co. KG | JEY | Class II | |
| K232010 | iTEMPSHIELD | Aion Biosystems | FLL | Class II | |
| K232006 | Legacy® Ipc | IG Technology Ltd | JOW | Class II | |
| K232005 | HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) | Smith & Nephew, Inc. | MBI | Class II | |
| K231404 | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button | Healthium MedTech Limited | MBI | Class II | |
| K231400 | Bladeless Trocar – Artemis Lap Cannula | T.A.G. Medical Products Corporation Ltd | GCJ | Class II | |
| K231370 | Dewin Blastocyst Medium (with HSA and without HSA) | Donnevie Medical Technology (Shanghai) Co., Ltd. | MQL | Class II | |
| K231333 | STRETTO™ Cable System | Globus Medical, Inc. | JDQ | Class II | |
| K230672 | Annabella Breast Pump | Annabella, Ltd. | HGX | Class II | |
| K230126 | Dentis s-Clean Regular Abutment | Dentis Co.,Ltd | NHA | Class II | |
| K223787 | ECGenius System | Cath Vision ApS | DQK | Class II | |
| K223673 | Surgeon Controlled Arm | Levita Magnetics International Corp. | PNL | Class II | |
| K223507 | CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) | Good Doctors Co., Ltd. | EBZ | Class II | |
| K223431 | Citric Complete Liquid Citric Acid Concentrate | Nipro Renal Solutions USA, Corporation | KPO | Class II | |
| K222635 | Premier Resolution System | Trinity Biotech (Primus Corporation dba Trinity Biotech) | GKA | Class II | |
| K221138 | Titus Titanium Cervical by SAGICO | Sagico VA USA, LLC | OVE | Class II | |
| K220031 | Alinity h-series System | Abbott Medical | GKZ | Class II | |
| K232132 | LifeSPARC System | Cardiacassist, Inc. | KFM | Class II | |
| K232058 | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | MQB | Class II | |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) | Atmos Medizintechnik GmbH & Co. KG | EOB | Class II | |
| K231831 | TiLink-L Joint Fusion System | Surgentec LLC | OUR | Class II | |
| K231654 | NorthStar OCT System | Seaspine, Inc. | NKG | Class II | |
| K231548 | Medical Diode Laser, Model S1Pro | Wuhan Pioon Technology Co.,Ltd. | GEX | Class II | |
| K231458 | Extremity Staple | restor3d, Inc. | JDR | Class II | |
| K230419 | Sequel Tampon with Plastic Applicator | Tampro Inc | HEB | Class II |