Cleared Traditional

K840202 - EPIDURAL CATHETER

K840202 is the FDA 510(k) clearance for EPIDURAL CATHETER by Aries Medical, Inc.. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K840202 · Aries Medical, Inc. · Anesthesiology device
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Feb 1984
Decision
39d
Days
Class 2
Risk

K840202 is an FDA 510(k) clearance for the EPIDURAL CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Aries Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 27, 1984 after a review of 39 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 Aries Medical, Inc. devices

Submission Details

510(k) Number K840202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date February 27, 1984
Days to Decision 39 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 140d · This submission: 39d
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 26
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K840202.
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