Cleared Traditional

K061143 - ROBERTSITE STOPCOCK

K061143 is an FDA 510(k) clearance for ROBERTSITE STOPCOCK, manufactured by Halkey-Roberts Corp.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K061143 · Halkey-Roberts Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
15d
Days
Class 2
Risk

K061143 is an FDA 510(k) clearance for the ROBERTSITE STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Halkey-Roberts Corp. (St. Petersburg, US). The FDA issued a Cleared decision on May 10, 2006 after a review of 15 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 - K061143

510(k) Number K061143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2006
Decision Date May 10, 2006
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FMG Device Classification - Class 2, Special Controls

Product Code FMG Stopcock, I.v. Set
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.
JEFFREY D RONGERO

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 - FMG Stopcock, I.v. Set

All 79
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K061143.
SMARTSITE STOPCOCK
K071400 · Cardinal Health, Alaris Products · Dec 2007
JMS PLANECTA STOPCOCK
K070143 · Jms North America Corp. · Apr 2007
BACSTOP
K053405 · Elcam Medical Acal · May 2006
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
K060231 · Elcam Medical Acal · Apr 2006
TRU-SWAB STOCOCK
K052330 · Medegen Medical Manufacturing Services · Sep 2005
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
K041779 · Nipro Medical Corp. · Sep 2004

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.

K061143 · ROBERTSITE STOPCOCK
Download PDF FDA Summary Halkey-Roberts Corp.