Cleared Traditional

K925362 - SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET

K925362 is an FDA 510(k) clearance for SUB-Q-SET SUBCUTANEOUS INFUSION SET, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K925362 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
310d
Days
Class 2
Risk

K925362 is an FDA 510(k) clearance for the SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on August 28, 1993 after a review of 310 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.

FDA 510(k) Submission Details - K925362

510(k) Number K925362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date August 28, 1993
Days to Decision 310 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
181d slower than avg
Panel avg: 129d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 1177
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K925362.
DURHAM
K930410 · Intl. Medical, Inc. · Sep 1993
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DURHAM
K930751 · Intl. Medical Consultants · Sep 1993
MPC-1000 INJECTION CAP/PLUG
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MPC-150 MALE TO MALE LUER ADAPTER
K925930 · Molded Products, Inc. · Aug 1993
EXEL HUBER INFUSION SET ROTATING WING
K926119 · Exel Intl. · Aug 1993
K925362 · SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
Download PDF FDA Summary Baxter Healthcare Corp