Cleared Traditional

K122661 - VITAL 5 RELEAF CATHETER

K122661 is an FDA 510(k) clearance for VITAL 5 RELEAF CATHETER, manufactured by Vital 5. The device is a Class 2 General & Plastic Surgery device with product code BSO cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K122661 · Vital 5 · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
180d
Days
Class 2
Risk

K122661 is an FDA 510(k) clearance for the VITAL 5 RELEAF CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Vital 5 (North Logan, US). The FDA issued a Cleared decision on February 27, 2013 after a review of 180 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 868.5120 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K122661

510(k) Number K122661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2012
Decision Date February 27, 2013
Days to Decision 180 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
65d slower than avg
Panel avg: 115d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSO Device Classification - Class 2, Special Controls

Product Code BSO Catheter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
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 - BSO Catheter, Conduction, Anesthetic

All 74
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K122661.
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K143164 · Kimberly Clark Corporation · Dec 2014
SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
K133316 · Epimed International, Inc. · May 2014
PAINFUSOR CATHETER
K111031 · Plan 1 Health, S.R.L. · Jul 2011
AMBIT TUNNELER
K110814 · Summit Medical Products, Inc. · Apr 2011
IO-FLEX CATHETER
K102594 · Baxano, Inc. · Jan 2011
K122661 · VITAL 5 RELEAF CATHETER
Download PDF FDA Summary Vital 5