Cleared Traditional

K863792 - DURACATH

K863792 is an FDA 510(k) clearance for DURACATH, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K863792 · Gish Biomedical, Inc. · Anesthesiology device
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Dec 1986
Decision
70d
Days
Class 2
Risk

K863792 is an FDA 510(k) clearance for the DURACATH, GISH MODEL NO. DVAC-XXXX. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on December 5, 1986 after a review of 70 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K863792

510(k) Number K863792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1986
Decision Date December 05, 1986
Days to Decision 70 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
70d faster than avg
Panel avg: 140d · This submission: 70d
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 41
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K863792.
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
SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
K854601 · Concord Laboratories, Inc. · Jan 1986
DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER
K850505 · Parke-Davis Co. · Mar 1985
DESERET EPIDURAL CATHETER
K850439 · Parke-Davis Co. · Mar 1985