Cleared Traditional

K193074 - Bevel Up Holder

K193074 is an FDA 510(k) clearance for Bevel Up Holder, 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 169-day FDA review.

K193074 · Nsp Tech Pte, Ltd. · General Hospital
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Apr 2020
Decision
169d
Days
Class 2
Risk

K193074 is an FDA 510(k) clearance for the Bevel Up Holder. 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 April 21, 2020 after a review of 169 days - an extended review cycle.

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. 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 Nsp Tech Pte, Ltd. devices

FDA 510(k) Submission Details - K193074

510(k) Number K193074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2019
Decision Date April 21, 2020
Days to Decision 169 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
40d slower than avg
Panel avg: 129d · This submission: 169d
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 K193074.
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