Cleared Traditional

K051401 - ON-Q CATHETER

K051401 is an FDA 510(k) clearance for ON-Q CATHETER, manufactured by I-Flow Corp.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K051401 · I-Flow Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
183d
Days
Class 2
Risk

K051401 is an FDA 510(k) clearance for the ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by I-Flow Corp. (Lake Forest, US). The FDA issued a Cleared decision on November 30, 2005 after a review of 183 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all I-Flow Corp. devices

FDA 510(k) Submission Details - K051401

510(k) Number K051401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2005
Decision Date November 30, 2005
Days to Decision 183 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 140d · This submission: 183d
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSO Catheter, Conduction, Anesthetic

All 41
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K051401.
BUSSE EPIDURAL CATHETER
K070465 · Busse Hospital Disposables, Inc. · Jul 2007
ON-Q INTRODUCERS
K063234 · I-Flow Corp. · Nov 2006
PORTEX EPIDURAL CATHETER
K062005 · Smiths Medical Asd, Inc. · Oct 2006
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
K051524 · Smiths Medical Asd, Inc. · Jul 2005
MODIFICATION TO SOAKER CATHETER
K043456 · I-Flow Corp. · Jan 2005
PERIFIX CATHETER AND CONTIPLEX CATHETER
K042488 · B.Braun Medical, Inc. · Sep 2004