Cleared Traditional

K897194 - PHARMASEAL EPIDURAL CATHETER & CONTINUO...

K897194 is the FDA 510(k) clearance for PHARMASEAL EPIDURAL CATHETER & CONTINUO... by Baxter Healthcare Corp. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K897194 · Baxter Healthcare Corp · Anesthesiology device
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Jun 1990
Decision
171d
Days
Class 2
Risk

K897194 is an FDA 510(k) clearance for the PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on June 18, 1990 after a review of 171 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K897194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1989
Decision Date June 18, 1990
Days to Decision 171 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 140d · This submission: 171d
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 K897194.
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
PHARMASEAL EPIDURAL CATHETER
K896712 · Baxter Healthcare Corp · Jun 1990
EPI-CATH(TM) EPIDURAL CATHETER
K895204 · Abbott Laboratories · Nov 1989
DURACATH, GISH MODEL NO. DVAC-XXXX
K863792 · Gish Biomedical, Inc. · Dec 1986
SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
K854601 · Concord Laboratories, Inc. · Jan 1986