Cleared Traditional

HIgH-Flo Super26 Subcutaneous Needle Sets (K180843) - 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
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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.

View all Repro-Med Systems, Inc. Dba Rms Medical Products devices

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
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

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