Cleared Traditional

K213690 - Eclipse Blood Collection Set

K213690 is an FDA 510(k) clearance for Eclipse Blood Collection Set, manufactured by Eclipse Medcorp, LLC. The device is a Class 2 General Hospital device with product code JKA cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K213690 · Eclipse Medcorp, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
337d
Days
Class 2
Risk

K213690 is an FDA 510(k) clearance for the Eclipse Blood Collection Set. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Eclipse Medcorp, LLC (The Colony, US). The FDA issued a Cleared decision on October 26, 2022 after a review of 337 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 Eclipse Medcorp, LLC devices

FDA 510(k) Submission Details - K213690

510(k) Number K213690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2021
Decision Date October 26, 2022
Days to Decision 337 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 129d · This submission: 337d
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 K213690.
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K223810 · Sb-Kawasumi Laboratories, Inc. · Feb 2023
Safety Push Button Blood Collection Set
K222834 · Jiangsu Caina Medical Co.,Ltd · Jan 2023
Steripath Micro Blood Collection System
K222299 · Magnolia Medical Technologies · Nov 2022
Safety Blood Collection Needle (Without Needle Holder)
K222141 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Oct 2022
Velano Vascular Blood Collection Adapter 
K201237 · Velano Vascular · Oct 2022
SOL-GUARD Safety Pull Button Collection Set
K213718 · Sol-Millennium Medical, Inc. · Aug 2022