Cleared Traditional

K043304 - Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01

K043304 is an FDA 510(k) clearance for Q-CAP NEEDLE-FREE RECONSTITUTION 13MM V..., manufactured by Bioject Medical Technologies, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K043304 · Bioject Medical Technologies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
45d
Days
Class 2
Risk

K043304 is an FDA 510(k) clearance for the Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Bioject Medical Technologies, Inc. (Bedminster, US). The FDA issued a Cleared decision on January 14, 2005 after a review of 45 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K043304

510(k) Number K043304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2004
Decision Date January 14, 2005
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 189
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K043304.
SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
K052790 · Cardinal Health, Alaris Products · Dec 2005
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K051669 · Migada Plant · Sep 2005
SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
K050339 · Laboratorios Grifols, S.A. · Feb 2005
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
K041222 · B.Braun Medical, Inc. · Oct 2004
BAXJECT II
K042410 · Baxter Healthcare Corp · Oct 2004
CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
K041691 · West Pharmaceutical Services, Inc. · Aug 2004
K043304 · Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
Download PDF FDA Summary Bioject Medical Techn…