Cleared Traditional

K122446 - LIQUIDBAND FLOW CONTROL

K122446 is an FDA 510(k) clearance for LIQUIDBAND FLOW CONTROL, manufactured by Advanced Medical Solutions (Plymouth), Ltd.. The device is a Class 2 General & Plastic Surgery device with product code MPN cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K122446 · Advanced Medical Solutions (Plymouth), Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
77d
Days
Class 2
Risk

K122446 is an FDA 510(k) clearance for the LIQUIDBAND FLOW CONTROL. Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Advanced Medical Solutions (Plymouth), Ltd. (Plymouth, GB). The FDA issued a Cleared decision on October 26, 2012 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4010 - the FDA general and plastic surgery 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 - K122446

510(k) Number K122446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2012
Decision Date October 26, 2012
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPN Device Classification - Class 2, Special Controls

Product Code MPN Tissue Adhesive For The Topical Approximation Of Skin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4010
Definition Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k).
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - MPN Tissue Adhesive For The Topical Approximation Of Skin

All 35
Devices cleared under the same product code (MPN) and FDA review panel - the closest regulatory comparables to K122446.
BARLE TISSUE ADHESIVE
K123133 · Advanced Medical Solutions (Plymouth), Ltd. · May 2013
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
K121976 · Aesculap, Inc. · May 2013
SURGISEAL TOPICAL SKIN ADHESIVE
K123936 · Adhezion Biomedical, LLC · Apr 2013
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
K111959 · Aesculap, Inc. · Feb 2012
LIQUIBAND FLOW CONTROL
K110184 · Medlogic Global Limited · Dec 2011
LIQUIBAND DUAL, MODEL LBD 001
K102076 · Medlogic Global Limited · Feb 2011