Cleared Traditional

K901129 - BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER

K901129 is the FDA 510(k) clearance for BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER by Medevice, Inc.. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K901129 · Medevice, Inc. · Anesthesiology device
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Mar 1990
Decision
18d
Days
Class 2
Risk

K901129 is an FDA 510(k) clearance for the BIO-MATE(TM) PEDIATRIC 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 March 30, 1990 after a review of 18 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 Medevice, Inc. devices

Submission Details

510(k) Number K901129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date March 30, 1990
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
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 K901129.
CATHETER SECUREMENT DEVICE
K951092 · Baxter Healthcare Corp · Mar 1995
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