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)
Optimized for regulatory review, auditing and printing
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
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 42
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K053405.
DUAL SYRINGE HOLDER
K082110 · Surgin Surgical Instrumentation, Inc. · Jun 2009
ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
K082836 · Icu Medical, Inc. · Feb 2009
CLAVE STOPCOCK
K080077 · Icu Medical, Inc. · Feb 2008
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
K041779 · Nipro Medical Corp. · Sep 2004
MANIFOLD WITH EXTENSION SET
K982368 · Interpore Cross Intl. · Jul 1998
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K974083 · Ohmeda Medical · Jan 1998