Cleared Traditional

K884969 - BIO-MATE(TM) EPIDURAL CATHETER

K884969 is the FDA 510(k) clearance for BIO-MATE(TM) EPIDURAL CATHETER by Medevice, Inc.. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K884969 · Medevice, Inc. · Anesthesiology device
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Jun 1989
Decision
205d
Days
Class 2
Risk

K884969 is an FDA 510(k) clearance for the BIO-MATE(TM) EPIDURAL CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Medevice, Inc. (Canada L4w 4m2, CA). The FDA issued a Cleared decision on June 23, 1989 after a review of 205 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 Medevice, Inc. devices

Submission Details

510(k) Number K884969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1988
Decision Date June 23, 1989
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 140d · This submission: 205d
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 24
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K884969.
PHARMASEAL EPIDURAL CATHETER
K896712 · Baxter Healthcare Corp · Jun 1990
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
EPINEED EPIDURAL CATHETER
K832232 · Terumo Medical Corp. · Aug 1983