Cleared Traditional

Insignis™ Syringe Infusion System (K232328) - FDA 510(k) Clearance

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

K232328 · Innovative Health Sciences, LLC · General Hospital
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Mar 2024
Decision
211d
Days
Class 2
Risk

K232328 is an FDA 510(k) clearance for the Insignis™ Syringe Infusion System. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Innovative Health Sciences, LLC (Chester, US). The FDA issued a Cleared decision on March 1, 2024 after a review of 211 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Innovative Health Sciences, LLC devices

Submission Details

510(k) Number K232328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2023
Decision Date March 01, 2024
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 238
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K232328.
I.V. Administration Set
K242126 · Bq Plus Medical Co., Ltd. · Aug 2024
Disposable infusion set with needle
K232475 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · May 2024
Disposable Extension Set
K222766 · Shandong Ande Healthcare Apparatus Co., Ltd. · Apr 2024
ResQ Administration Set
K231707 · Q For Plastic Industries · Jan 2024
Extension Set
K230528 · Medcaptain Life Science Co., Ltd. · Dec 2023
LILY Extension Tube and Needleless Connector
K222780 · Lily Medical Corporation · Nov 2023