Cleared Traditional

SELEC-3 (K925645) - FDA 510(k) Clearance

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

K925645 · Biomedix, Inc. · General Hospital
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Sep 1993
Decision
322d
Days
Class 2
Risk

K925645 is an FDA 510(k) clearance for the SELEC-3. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Biomedix, Inc. (Spencer, US). The FDA issued a Cleared decision on September 27, 1993 after a review of 322 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 Biomedix, Inc. devices

Submission Details

510(k) Number K925645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date September 27, 1993
Days to Decision 322 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
193d slower than avg
Panel avg: 129d · This submission: 322d
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 226
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K925645.
CONTROL-A-FLO(TM) REGULATOR
K940867 · Baxter Healthcare Corp · May 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
K933326 · Abbott Laboratories · Mar 1994
ENERGIZED CONTAINER SYSTEM
K925418 · Abbott Laboratories · Nov 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
K925362 · Baxter Healthcare Corp · Aug 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
K925058 · C.R. Bard, Inc. · Aug 1993
BAXTER SOLUTION ADMINISTRATION SETS
K924721 · Baxter Healthcare Corp · Jul 1993