Cleared Traditional

Eclipse Blood Collection Set (K213690) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213690 · Eclipse Medcorp, LLC · General Hospital
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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

Submission Details

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.

Device Classification

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 100
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