Cleared Traditional

K241803 - INSULCLOCK® v2.0 PRO (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241803 · Insulcloud S.L. · General Hospital
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Aug 2024
Decision
62d
Days
Class 2
Risk

K241803 is an FDA 510(k) clearance for the INSULCLOCK® v2.0 PRO. Classified as Injection Data Capture Device (product code QOG), Class II - Special Controls.

Submitted by Insulcloud S.L. (Bibao, ES). The FDA issued a Cleared decision on August 22, 2024 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Insulcloud S.L. devices

Submission Details

510(k) Number K241803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2024
Decision Date August 22, 2024
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QOG Injection Data Capture Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
Definition An Injection Data Capture Device Is An Electrically-powered/electromechanical Accessory That Interfaces With Reusable Or Disposable Injection Devices For The Purposes Of Interpreting, Recording And Displaying And/or Transmitting Injection Data To A Connected Application Or Software.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

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