Cleared Traditional

K896712 - PHARMASEAL EPIDURAL CATHETER

K896712 is an FDA 510(k) clearance for PHARMASEAL EPIDURAL CATHETER, 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 202-day FDA review.

K896712 · Baxter Healthcare Corp · Anesthesiology device
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Jun 1990
Decision
202d
Days
Class 2
Risk

K896712 is an FDA 510(k) clearance for the PHARMASEAL EPIDURAL CATHETER. 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 202 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

FDA 510(k) Submission Details - K896712

510(k) Number K896712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1989
Decision Date June 18, 1990
Days to Decision 202 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
62d slower than avg
Panel avg: 140d · This submission: 202d
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 K896712.
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
PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL
K897194 · 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