Cleared Abbreviated

K042410 - BAXJECT II

K042410 is an FDA 510(k) clearance for BAXJECT II, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code LHI cleared through the Abbreviated 510(k) pathway after a 31-day FDA review.

K042410 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
31d
Days
Class 2
Risk

K042410 is an FDA 510(k) clearance for the BAXJECT II. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Westlake Village, US). The FDA issued a Cleared decision on October 8, 2004 after a review of 31 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K042410

510(k) Number K042410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2004
Decision Date October 08, 2004
Days to Decision 31 days
Submission Type Abbreviated
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
98d faster than avg
Panel avg: 129d · This submission: 31d
Pathway characteristics
Standards-based clearance path.

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 134
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K042410.
SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
K050339 · Laboratorios Grifols, S.A. · Feb 2005
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
K043304 · Bioject Medical Technologies, Inc. · Jan 2005
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
K041222 · B.Braun Medical, Inc. · Oct 2004
CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
K041691 · West Pharmaceutical Services, Inc. · Aug 2004
GETTIG UNIVERSAL VIAL ACCESS PIN
K041232 · Gettig Pharmaceutical Instrument Co. · Jul 2004
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
K041564 · Bioject Medical Technologies, Inc. · Jul 2004