Cleared Traditional

SUBCUTANEOUS INFUSION SET (K920537) - FDA 510(k) Clearance

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

K920537 · Marquette Medical, Inc. · General Hospital
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Oct 1992
Decision
251d
Days
Class 2
Risk

K920537 is an FDA 510(k) clearance for the SUBCUTANEOUS INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Marquette Medical, Inc. (Crofton, US). The FDA issued a Cleared decision on October 13, 1992 after a review of 251 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 Marquette Medical, Inc. devices

Submission Details

510(k) Number K920537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1992
Decision Date October 13, 1992
Days to Decision 251 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 129d · This submission: 251d
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 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K920537.
INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET
K921899 · Baxter Healthcare Corp · Apr 1993
LIFESHIELD ANESTHESIA SET
K913982 · Abbott Laboratories · Nov 1992
INTERLINK(TM) INJECTION SITE
K922558 · Baxter Healthcare Corp · Oct 1992
MERIT ADMINISTRATION SET
K915678 · Merit Medical Systems, Inc. · Jul 1992
CONTINU-FLO(R) SOLUTION SET
K921703 · Baxter Healthcare Corp · Jun 1992
INJECTION SITE WITH LUER LOCK
K915828 · Baxter Healthcare Corp · May 1992