Cleared Traditional

K984060 - LUER ACCESS INJECTION SITE

K984060 is an FDA 510(k) clearance for LUER ACCESS INJECTION SITE, 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 255-day FDA review.

K984060 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
255d
Days
Class 2
Risk

K984060 is an FDA 510(k) clearance for the LUER ACCESS INJECTION SITE. 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 July 26, 1999 after a review of 255 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K984060

510(k) Number K984060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1998
Decision Date July 26, 1999
Days to Decision 255 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
126d slower than avg
Panel avg: 129d · This submission: 255d
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 791
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K984060.
INTRAVASCULAR ADMINISTRATION SET
K991932 · The Kipp Group · Aug 1999
COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
K991985 · Cook, Inc. · Aug 1999
AB2 MED-FLO SOLUTION SET
K984569 · Ab2 Medical Products, Llp · Aug 1999
ANESFLOW-DUAL DRIP IV INFUSION SET
K990496 · Innovative Design Assoc. · Jul 1999
MAERSK MEDICAL CONTOUR INFUSION SET
K991759 · Maersk Medical A/S · Jun 1999
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
K991653 · Rymed Technologies, Inc. · Jun 1999