Cleared Traditional

K951092 - CATHETER SECUREMENT DEVICE

K951092 is the FDA 510(k) clearance for CATHETER SECUREMENT DEVICE by Baxter Healthcare Corp. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K951092 · Baxter Healthcare Corp · Anesthesiology device
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Mar 1995
Decision
15d
Days
Class 2
Risk

K951092 is an FDA 510(k) clearance for the CATHETER SECUREMENT DEVICE. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Deerfield Lake, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K951092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1995
Decision Date March 24, 1995
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K951092.
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K023233 · Ebi, L.P. · Dec 2002
PERIFIX CATHETER CONNECTOR
K022019 · B.Braun Medical, Inc. · Aug 2002
SPIROL EPIDURAL CATHETER
K000886 · Abbott Laboratories · Oct 2000
MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY
K930539 · Medical Components, Inc. · Aug 1993
KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE
K930219 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1993
KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH
K922113 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1992