Cleared Traditional

K232308 - Monarch Blood Collection Set

K232308 is an FDA 510(k) clearance for Monarch Blood Collection Set, manufactured by The Monarch Company. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K232308 · The Monarch Company · General Hospital
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Dec 2023
Decision
124d
Days
Class 2
Risk

K232308 is an FDA 510(k) clearance for the Monarch Blood Collection Set. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by The Monarch Company (Birmingham, US). The FDA issued a Cleared decision on December 4, 2023 after a review of 124 days - within the typical 510(k) review window.

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 The Monarch Company devices

FDA 510(k) Submission Details - K232308

510(k) Number K232308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2023
Decision Date December 04, 2023
Days to Decision 124 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
5d faster than avg
Panel avg: 129d · This submission: 124d
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 122
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K232308.
BD Vacutainer® Fluoride Blood Collection Tubes
K231237 · Becton, Dickinson and Company · Jan 2024
Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
K232881 · Jiangsu Kangbao Medical Equipment Co., Ltd. · Dec 2023
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes
K230855 · Becton, Dickinson and Company · Dec 2023
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube
K230391 · Becton, Dickinson and Company · Dec 2023
Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
K213146 · Jiangsu Rongye Technology Co., Ltd. · Oct 2023
UltraFlo-R Push Button Blood Collection Set
K220458 · Innovative Medical Technologies, Inc. · Sep 2023