Cleared Traditional

K232781 - Safety Sliding Blood Collection Set

K232781 is an FDA 510(k) clearance for Safety Sliding Blood Collection Set, manufactured by Jiangsu Caina Medical Co.,Ltd. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K232781 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
178d
Days
Class 2
Risk

K232781 is an FDA 510(k) clearance for the Safety Sliding Blood Collection Set. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on March 7, 2024 after a review of 178 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 Jiangsu Caina Medical Co.,Ltd devices

FDA 510(k) Submission Details - K232781

510(k) Number K232781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2023
Decision Date March 07, 2024
Days to Decision 178 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
49d slower than avg
Panel avg: 129d · This submission: 178d
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 164
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K232781.
PIVO™ Pro Needle-free Blood Collection Device
K241586 · Becton Dickinson Infusion Therapy Systems, Inc. · Feb 2025
BD Vacutainer® One Use Holder
K242320 · Becton, Dickinson and Company · Nov 2024
VACUETTE® QUICKSHIELD Complete (Plus)
K233979 · Greiner Bio-One North America, Inc. · Jul 2024
BD Vacutainer® K2 EDTA Blood Collection Tubes
K231373 · Becton, Dickinson and Company · Feb 2024
LifeOutcomes C-Quest™ Blood Culture Sampling Device
K231282 · Lifeoutcomes, LLC · Jan 2024
BD Vacutainer® Fluoride Blood Collection Tubes
K231237 · Becton, Dickinson and Company · Jan 2024