Cleared Traditional

K951092 - CATHETER SECUREMENT DEVICE

K951092 is an FDA 510(k) clearance for CATHETER SECUREMENT DEVICE, manufactured by Baxter Healthcare Corp. The device is a Class 2 Anesthesiology device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K951092

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.

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 62
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K951092.
INTERPLEURAL ANESTHESIA CATHETER
K971851 · Axiom Medical, Inc. · Jan 1998
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
K951927 · Csen , Ltd. · May 1997
RACZ EPIDURAL CATHETER
K954584 · Medic Evaluation Devices & Instruments Corp. · Oct 1996
CONCORD/PORTEX EPIDURAL CATHETERS
K935927 · Smiths Industries Medical Systems, Inc. · Sep 1994
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