Cleared Traditional

K181754 - Blood Collection Accessory (BUCA)

K181754 is an FDA 510(k) clearance for Blood Collection Accessory (BUCA), manufactured by Nsp Tech Pte, Ltd.. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K181754 · Nsp Tech Pte, Ltd. · General Hospital
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Jul 2019
Decision
393d
Days
Class 2
Risk

K181754 is an FDA 510(k) clearance for the Blood Collection Accessory (BUCA). Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Nsp Tech Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on July 30, 2019 after a review of 393 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: 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 Nsp Tech Pte, Ltd. devices

FDA 510(k) Submission Details - K181754

510(k) Number K181754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2018
Decision Date July 30, 2019
Days to Decision 393 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
264d slower than avg
Panel avg: 129d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

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 119
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K181754.
Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)
K191832 · Kurin, Inc. · Feb 2020
PIVO(TM)
K193569 · Velano Vascular · Jan 2020
Blood Transfer Accessory (BTA)
K181743 · Nsp Tech Pte, Ltd. · Jul 2019
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K190485 · Kawasumi Laboratories, Inc. · Jul 2019
PIVO
K190604 · Velano Vascular · May 2019
MiniCollect K2E K2EDTA Tubes
K182078 · Greiner Bio-One Na, Inc. · Jan 2019