Cleared Special

K212860 - SmartBand EMR Kit (SB-EMR-K

K212860 is the FDA 510(k) clearance for SmartBand EMR Kit (SB-EMR-K by STERIS Corporation. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Special 510(k) pathway after a 29-day FDA review.

K212860 · STERIS Corporation · Gastroenterology & Urology device
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Oct 2021
Decision
29d
Days
Class 2
Risk

K212860 is an FDA 510(k) clearance for the SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (.... Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on October 7, 2021 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all STERIS Corporation devices

Submission Details

510(k) Number K212860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2021
Decision Date October 07, 2021
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FDI Snare, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDI Snare, Flexible

All 40
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K212860.
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