Cleared Traditional

K850505 - DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER

K850505 is an FDA 510(k) clearance for DESERET EPIDURAL CATHETER W/TOUGHY-BORS..., manufactured by Parke-Davis Co.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K850505 · Parke-Davis Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
31d
Days
Class 2
Risk

K850505 is an FDA 510(k) clearance for the DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Parke-Davis Co. (Rochester, US). The FDA issued a Cleared decision on March 11, 1985 after a review of 31 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 Parke-Davis Co. devices

FDA 510(k) Submission Details - K850505

510(k) Number K850505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date March 11, 1985
Days to Decision 31 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
109d faster than avg
Panel avg: 140d · This submission: 31d
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 45
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K850505.
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
DESERET EPIDURAL CATHETER
K850439 · Parke-Davis Co. · Mar 1985
EPIDURAL CATHETER
K840202 · Aries Medical, Inc. · Feb 1984
3-DAY RELEASE OF ETHYLENE OXIDE DEVICE
K832352 · Parke-Davis Co. · Jan 1984