Cleared Traditional

K201936 - SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (FDA 510(k) Clearance)

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

K201936 · Gilero, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
May 2021
Decision
297d
Days
Class 2
Risk

K201936 is an FDA 510(k) clearance for the SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Gilero, LLC (Morrisville, US). The FDA issued a Cleared decision on May 6, 2021 after a review of 297 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Gilero, LLC devices

Submission Details

510(k) Number K201936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2020
Decision Date May 06, 2021
Days to Decision 297 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 128d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPE Container, I.v.

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