Cleared Traditional

K181870 - Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use

K181870 is an FDA 510(k) clearance for Infusion Sets with Precision Filter for..., manufactured by Wuhan W.E.O Science & Technology Development Co., Ltd.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K181870 · Wuhan W.E.O Science & Technology Development Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2019
Decision
229d
Days
Class 2
Risk

K181870 is an FDA 510(k) clearance for the Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Wuhan W.E.O Science & Technology Development Co., Ltd. (Wuhun, CN). The FDA issued a Cleared decision on February 26, 2019 after a review of 229 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 Wuhan W.E.O Science & Technology Development Co., Ltd. devices

FDA 510(k) Submission Details - K181870

510(k) Number K181870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2018
Decision Date February 26, 2019
Days to Decision 229 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
100d slower than avg
Panel avg: 129d · This submission: 229d
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

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