Cleared Traditional

K210381 - I.V. Administration Set

K210381 is an FDA 510(k) clearance for I.V. Administration Set, manufactured by Bq Plus Medical Co., Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K210381 · Bq Plus Medical Co., Ltd. · General Hospital
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Aug 2021
Decision
186d
Days
Class 2
Risk

K210381 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 14, 2021 after a review of 186 days - an extended review cycle.

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

FDA 510(k) Submission Details - K210381

510(k) Number K210381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2021
Decision Date August 14, 2021
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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

Mid-Link Consulting Co, Ltd.
Diana Hong

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

All 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K210381.
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