Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Safety Insulin Pen Needles

K-Number: K213183 · 2022-10-14

ApplicantZhejiang Kindly Medical Devices Co., Ltd.
Decision Date2022-10-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Insulin Pen Needles is a medical device manufactured by Zhejiang Kindly Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-10-14 under approval number K213183. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Safety Insulin Pen Needles?

Safety Insulin Pen Needles is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Zhejiang Kindly Medical Devices Co., Ltd.. The 510(k) number is K213183.

When was Safety Insulin Pen Needles approved by the FDA?

Safety Insulin Pen Needles received FDA 510(k) clearance on 2022-10-14, under approval number K213183.

What company makes Safety Insulin Pen Needles?

Safety Insulin Pen Needles is manufactured by Zhejiang Kindly Medical Devices Co., Ltd..

What is the FDA product code for Safety Insulin Pen Needles?

The FDA product code for Safety Insulin Pen Needles is FMI.

Related Clinical Trials

NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07602036 Type 2 Diabetes and Pregnancy a Single-arm Interventional Study NOT_YET_RECRUITING NCT05785832 A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes COMPLETED

Other Devices by Zhejiang Kindly Medical Devices Co., Ltd.

K181069Disposable Insulin Pen Needle K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles K223334Sterile Hypodermic Needles for Single Use

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑