Cleared Traditional

K041564 - Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01

K041564 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 36-day FDA review.

K041564 · Bioject Medical Technologies, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
36d
Days
Class 2
Risk

K041564 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 July 16, 2004 after a review of 36 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.

View all Bioject Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K041564

510(k) Number K041564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2004
Decision Date July 16, 2004
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
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 86
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K041564.
NEXUS I.V. FLUID TRANSFER DEVICE
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BAXJECT II
K042410 · Baxter Healthcare Corp · Oct 2004
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003
CHEMO-AIDE DISPENSING PIN
K003730 · Baxter Healthcare Corp · Dec 2000
KAWASUMI LABORATORIES PHILEBOTOMY SET
K994323 · Kawasumi Laboratories Co., Ltd. · Mar 2000