Cleared Traditional

K884969 - BIO-MATE(TM) EPIDURAL CATHETER

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

K884969 · Medevice, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K884969

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.

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 51
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
SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
K854601 · Concord Laboratories, Inc. · Jan 1986
EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
K850009 · Vas-Cath of Canada , Ltd. · May 1985