Cleared Traditional

K180843 - HIgH-Flo Super26 Subcutaneous Needle Sets (FDA 510(k) Clearance)

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

K180843 · Repro-Med Systems, Inc. Dba Rms Medical Products · General Hospital
Apr 2019
Decision
367d
Days
Class 2
Risk

K180843 is an FDA 510(k) clearance for the HIgH-Flo Super26 Subcutaneous Needle Sets. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Repro-Med Systems, Inc. Dba Rms Medical Products (New York, US). The FDA issued a Cleared decision on April 4, 2019 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.

Submission Details

510(k) Number K180843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2018
Decision Date April 04, 2019
Days to Decision 367 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 169d · 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 29
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