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 Pen Needle

K-Number: K210864 · 2022-02-17

ApplicantSandstone Medical (Suzhou), Inc.
Decision Date2022-02-17
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Pen Needle is a medical device manufactured by Sandstone Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2022-02-17 under approval number K210864. 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 Pen Needle?

Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2022-02-17. It is manufactured by Sandstone Medical (Suzhou), Inc.. The 510(k) number is K210864.

When was Safety Pen Needle approved by the FDA?

Safety Pen Needle received FDA 510(k) clearance on 2022-02-17, under approval number K210864.

What company makes Safety Pen Needle?

Safety Pen Needle is manufactured by Sandstone Medical (Suzhou), Inc..

What is the FDA product code for Safety Pen Needle?

The FDA product code for Safety Pen Needle is FMI.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT06828250 Intradermal Needle Therapy Relieves Postoperative Pain After Endoscopic Submucosal Dissection (ESD) COMPLETED

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Sandstone Medical (Suzhou), Inc.

K193422Easydrip Pen Needle, Easydrip Plus Pen Needle K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle

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.

↑