FDA 510(k)

INSULCLOCK® v2.0 PRO

K-Number: K241803 · 2024-08-22

Decision Date2024-08-22

Product CodeQOG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INSULCLOCK® v2.0 PRO is the device name listed in this FDA 510(k) record. The listed applicant is Insulcloud S.L.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241803. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSULCLOCK® v2.0 PRO?

INSULCLOCK® v2.0 PRO is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Insulcloud S.L.. The 510(k) number is K241803.

When did INSULCLOCK® v2.0 PRO receive FDA 510(k) clearance?

INSULCLOCK® v2.0 PRO received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241803.

Who is the listed applicant for INSULCLOCK® v2.0 PRO?

The FDA 510(k) record lists Insulcloud S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSULCLOCK® v2.0 PRO?

The FDA product code for INSULCLOCK® v2.0 PRO is QOG.

Related Devices (Code: QOG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243901SmartPilot YpsoMate NS-A2.25Ypsomed AG K251500MallyaG Injection Pen Adapter (MallyaG)Biocorp Production K250555MallyaD injection pen adapter (MallyaD)Biocorp Production K231820SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp Production K222689Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp Production K212217Tempo Smart ButtonEli Lilly and Company

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.