Cleared Traditional

K915828 - INJECTION SITE WITH LUER LOCK

K915828 is an FDA 510(k) clearance for INJECTION SITE WITH LUER LOCK, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K915828 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
137d
Days
Class 2
Risk

K915828 is an FDA 510(k) clearance for the INJECTION SITE WITH LUER LOCK. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 15, 1992 after a review of 137 days - within the typical 510(k) review window.

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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K915828

510(k) Number K915828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1991
Decision Date May 15, 1992
Days to Decision 137 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
8d slower than avg
Panel avg: 129d · This submission: 137d
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 793
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K915828.
SOLUTION ADMINISTRATION SET
K921391 · Douglas Medical Products Corp. · Sep 1992
MERIT ADMINISTRATION SET
K915678 · Merit Medical Systems, Inc. · Jul 1992
CONTINU-FLO(R) SOLUTION SET
K921703 · Baxter Healthcare Corp · Jun 1992
RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET
K915109 · Ballard Medical Products · 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