Cleared Traditional

K053405 - BACSTOP

K053405 is an FDA 510(k) clearance for BACSTOP, manufactured by Elcam Medical Acal. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K053405 · Elcam Medical Acal · General Hospital
Download Printable Device Report (PDF)
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May 2006
Decision
155d
Days
Class 2
Risk

K053405 is an FDA 510(k) clearance for the BACSTOP. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Elcam Medical Acal (Mp. Merom Hagalil, IL). The FDA issued a Cleared decision on May 11, 2006 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Elcam Medical Acal devices

FDA 510(k) Submission Details - K053405

510(k) Number K053405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2005
Decision Date May 11, 2006
Days to Decision 155 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K053405.
CLAVE STOPCOCK
K080077 · Icu Medical, Inc. · Feb 2008
SMARTSITE STOPCOCK
K071400 · Cardinal Health, Alaris Products · Dec 2007
JMS PLANECTA STOPCOCK
K070143 · Jms North America Corp. · Apr 2007
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
TRU-SWAB STOCOCK
K052330 · Medegen Medical Manufacturing Services · Sep 2005