Cleared Traditional

K052330 - TRU-SWAB STOCOCK

K052330 is an FDA 510(k) clearance for TRU-SWAB STOCOCK, manufactured by Medegen Medical Manufacturing Services. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K052330 · Medegen Medical Manufacturing Services · General Hospital
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Sep 2005
Decision
14d
Days
Class 2
Risk

K052330 is an FDA 510(k) clearance for the TRU-SWAB STOCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Medegen Medical Manufacturing Services (Ontario, US). The FDA issued a Cleared decision on September 9, 2005 after a review of 14 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 Medegen Medical Manufacturing Services devices

FDA 510(k) Submission Details - K052330

510(k) Number K052330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2005
Decision Date September 09, 2005
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
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

Regulatory Technology Services, LLC
MARK JOB

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 60
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K052330.
BACSTOP
K053405 · Elcam Medical Acal · May 2006
ROBERTSITE STOPCOCK
K061143 · Halkey-Roberts Corp. · May 2006
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
K060231 · Elcam Medical Acal · Apr 2006
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
K041779 · Nipro Medical Corp. · Sep 2004
INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK)
K032393 · Elcam Medical Acal · Sep 2003
ELCAM STOPCOCKS AND MANIFOLDS
K022895 · Medical Device Consultants, Inc. · Oct 2002

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.