Cleared Traditional

K151991 - Safelock Disposable Blood Collection Set

K151991 is the FDA 510(k) clearance for Safelock Disposable Blood Collection Set by Jiangyin Caina Technology Co., Ltd.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K151991 · Jiangyin Caina Technology Co., Ltd. · General Hospital
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Dec 2015
Decision
144d
Days
Class 2
Risk

K151991 is an FDA 510(k) clearance for the Safelock Disposable Blood Collection Set, Disposable Blood Collection Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Jiangyin Caina Technology Co., Ltd. (Jiangyin, CN). The FDA issued a Cleared decision on December 11, 2015 after a review of 144 days - within the typical 510(k) review window.

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 Jiangyin Caina Technology Co., Ltd. devices

Submission Details

510(k) Number K151991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2015
Decision Date December 11, 2015
Days to Decision 144 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 129d · This submission: 144d
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 Peers - FPA Set, Administration, Intravascular

All 449
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