Cleared Special

I.V. Administration Set (K242126) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242126 · Bq Plus Medical Co., Ltd. · General Hospital
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Aug 2024
Decision
34d
Days
Class 2
Risk

K242126 is an FDA 510(k) clearance for the I.V. Administration Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Bq Plus Medical Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 22, 2024 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 Bq Plus Medical Co., Ltd. devices

Submission Details

510(k) Number K242126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2024
Decision Date August 22, 2024
Days to Decision 34 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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

Shanghai SUNGO Management Consulting Co., Ltd.
Eva Li

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 - FPA Set, Administration, Intravascular

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