Cleared Traditional

RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET (K915109) - FDA 510(k) Clearance

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

K915109 · Ballard Medical Products · General Hospital
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May 1992
Decision
177d
Days
Class 2
Risk

K915109 is an FDA 510(k) clearance for the RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on May 8, 1992 after a review of 177 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 Ballard Medical Products devices

Submission Details

510(k) Number K915109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1991
Decision Date May 08, 1992
Days to Decision 177 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
48d slower than avg
Panel avg: 129d · This submission: 177d
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 238
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K915109.
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
8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET
K920694 · Baxter Healthcare Corp · Mar 1992
3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES
K915390 · Baxter Healthcare Corp · Mar 1992
NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE
K914048 · Baxter Healthcare Corp · Nov 1991