Cleared Traditional

K915109 - RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSI...

K915109 is an FDA 510(k) clearance for RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSI..., manufactured by Ballard Medical Products. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 177-day FDA review.

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

FDA 510(k) Submission Details - K915109

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
Combination Product No
PCCP Authorized No
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.

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 532
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
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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
INJECTION CAP
K913337 · Cp Medical · Feb 1992