Cleared Traditional

K040634 - ROBERTSITE VIAL ADAPTER, MODEL 245700021

K040634 is an FDA 510(k) clearance for ROBERTSITE VIAL ADAPTER, manufactured by Halkey-Roberts Corp.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K040634 · Halkey-Roberts Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
13d
Days
Class 2
Risk

K040634 is an FDA 510(k) clearance for the ROBERTSITE VIAL ADAPTER, MODEL 245700021. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Halkey-Roberts Corp. (St. Petersburg, US). The FDA issued a Cleared decision on March 23, 2004 after a review of 13 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 - K040634

510(k) Number K040634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date March 23, 2004
Days to Decision 13 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 129d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
SUSAN GILL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 206
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K040634.
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
FLEBOSET MULTIPLE
K040456 · Laboratorios Grifols, S.A. · Mar 2004
SET GRI-FILL 2.0-1 WAY
K033682 · Laboratorios Grifols, S.A. · Dec 2003
MIX2VIAL TRANSFER DEVICE
K031861 · Medimop Medical Projects, Ltd. · Jul 2003

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K040634 · ROBERTSITE VIAL ADAPTER, MODEL 245700021
Download PDF FDA Summary Halkey-Roberts Corp.