Cleared Traditional

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen (K213146) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213146 · Jiangsu Rongye Technology Co., Ltd. · General Hospital
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Oct 2023
Decision
760d
Days
Class 2
Risk

K213146 is an FDA 510(k) clearance for the Safety butterfly type blood collection needle, Butterfly type blood collectio.... Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Jiangsu Rongye Technology Co., Ltd. (Jiangsu, CN). The FDA issued a Cleared decision on October 27, 2023 after a review of 760 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.1675 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Jiangsu Rongye Technology Co., Ltd. devices

Submission Details

510(k) Number K213146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date October 27, 2023
Days to Decision 760 days
Submission Type Traditional
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
631d slower than avg
Panel avg: 129d · This submission: 760d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 100
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K213146.
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BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes
K213953 · Becton, Dickinson and Company · Jul 2023