Cleared Traditional

K010623 - RECONSTITUTION KIT & VIAL CONNECTOR

K010623 is an FDA 510(k) clearance for RECONSTITUTION KIT & VIAL CONNECTOR, manufactured by Bioject, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K010623 · Bioject, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
34d
Days
Class 2
Risk

K010623 is an FDA 510(k) clearance for the RECONSTITUTION KIT & VIAL CONNECTOR. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Bioject, Inc. (Portland, US). The FDA issued a Cleared decision on April 5, 2001 after a review of 34 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, Inc. devices

FDA 510(k) Submission Details - K010623

510(k) Number K010623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2001
Decision Date April 05, 2001
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 142
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K010623.
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
K041564 · Bioject Medical Technologies, Inc. · Jul 2004
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003
SINGLE DOSE DISPENSING PIN, MODEL 2201
K013087 · Alaris Medical Systems, Inc. · Nov 2001
CHEMO-AIDE DISPENSING PIN
K003730 · Baxter Healthcare Corp · Dec 2000
KAWASUMI LABORATORIES PHILEBOTOMY SET
K994323 · Kawasumi Laboratories Co., Ltd. · Mar 2000
CODAN CHEMOSPIKE
K990711 · Codan US Corp. · Apr 1999