Cleared Traditional

K191362 - LifeFlow Blood System

K191362 is the FDA 510(k) clearance for LifeFlow Blood System by 410 Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K191362 · 410 Medical, Inc. · General Hospital
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May 2020
Decision
364d
Days
Class 2
Risk

K191362 is an FDA 510(k) clearance for the LifeFlow Blood System. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by 410 Medical, Inc. (Durham, US). The FDA issued a Cleared decision on May 20, 2020 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 410 Medical, Inc. devices

Submission Details

510(k) Number K191362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2019
Decision Date May 20, 2020
Days to Decision 364 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
235d slower than avg
Panel avg: 129d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

MRC Global, LLC
Danielle Besal

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 445
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K191362.
TK Intravascular Administration Set
K191640 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2020
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K192681 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Jul 2020
Intravascular Extension Sets and Accessories
K192366 · Baxter Healthcare Corporation · Jul 2020
IV Sets not made with PVC
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Flowart
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K192647 · Unomedical A/S · Dec 2019