Cleared Traditional

Insignis Subcutaneous Needle Sets (K202279) - FDA 510(k) Clearance

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

K202279 · Innovative Health Sciences, LLC · General Hospital
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Aug 2021
Decision
367d
Days
Class 2
Risk

K202279 is an FDA 510(k) clearance for the Insignis Subcutaneous Needle Sets. 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 August 13, 2021 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Innovative Health Sciences, LLC devices

Submission Details

510(k) Number K202279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2020
Decision Date August 13, 2021
Days to Decision 367 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
238d slower than avg
Panel avg: 129d · This submission: 367d
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 K202279.
Intravascular Administration Sets
K203609 · Baxter Healthcare Corporation · Sep 2021
IV Administration Sets
K202618 · B.Braun Medical, Inc. · Sep 2021
I.V. Administration Set
K210381 · Bq Plus Medical Co., Ltd. · Aug 2021
Firefly Needleless Connector
K203796 · Puracath Medical, Inc. · Jul 2021
Medtronic Extended infusion set
K210544 · Unomedical A/S · Jul 2021
Intravascular Extension Set
K210430 · Baxter Healthcare Corporation · Jun 2021