Cleared Traditional

K211160 - EndoTool SubQ 2.1

K211160 is an FDA 510(k) clearance for EndoTool SubQ 2.1, manufactured by Monarch Medical Technologies, LLC. The device is a Class 2 Chemistry device with product code NDC cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K211160 · Monarch Medical Technologies, LLC · Chemistry device
Download Printable Device Report (PDF)
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Oct 2021
Decision
192d
Days
Class 2
Risk

K211160 is an FDA 510(k) clearance for the EndoTool SubQ 2.1. Classified as Calculator, Drug Dose (product code NDC), Class II - Special Controls.

Submitted by Monarch Medical Technologies, LLC (Charlotte, US). The FDA issued a Cleared decision on October 28, 2021 after a review of 192 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 868.1890 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Monarch Medical Technologies, LLC devices

FDA 510(k) Submission Details - K211160

510(k) Number K211160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2021
Decision Date October 28, 2021
Days to Decision 192 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 88d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDC Device Classification - Class 2, Special Controls

Product Code NDC Calculator, Drug Dose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 Chemistry devices follow this clearance model.

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