Cleared Traditional

K023539 - STERI-SPOUTS

Also marketed or referenced as:
BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER RAPIDFLOW, VIALFLOW, TRANSFLOW

K023539 is an FDA 510(k) clearance for STERI-SPOUTS, manufactured by Valumed. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K023539 · Valumed · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
56d
Days
Class 2
Risk

K023539 is an FDA 510(k) clearance for the STERI-SPOUTS. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Valumed (Niceville, US). The FDA issued a Cleared decision on December 17, 2002 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K023539

510(k) Number K023539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2002
Decision Date December 17, 2002
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 206
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K023539.
SET GRI-FILL 2.0-1 WAY
K033682 · Laboratorios Grifols, S.A. · Dec 2003
MIX2VIAL TRANSFER DEVICE
K031861 · Medimop Medical Projects, Ltd. · Jul 2003
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003
PHASEAL
K023747 · Carmel Pharma Ab. · Nov 2002
RAPID-FILL TUBESET, MODEL 90005
K022523 · Baxa Corp. · Aug 2002
ANGELTOUCH VENTED IV ADMINISTRATION SET
K012189 · Angiplast Private , Ltd. · Mar 2002
K023539 · STERI-SPOUTS
Download PDF FDA Summary Valumed