Cleared Traditional

K840202 - EPIDURAL CATHETER

K840202 is an FDA 510(k) clearance for EPIDURAL CATHETER, manufactured by Aries Medical, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K840202

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
Combination Product No
PCCP Authorized No
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.

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 K840202.
EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
K850009 · Vas-Cath of Canada , Ltd. · May 1985
DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER
K850505 · Parke-Davis Co. · Mar 1985
DESERET EPIDURAL CATHETER
K850439 · Parke-Davis Co. · Mar 1985
3-DAY RELEASE OF ETHYLENE OXIDE DEVICE
K832352 · Parke-Davis Co. · Jan 1984
EPINEED EPIDURAL CATHETER
K832232 · Terumo Medical Corp. · Aug 1983
CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG
K802065 · Portex, Inc. · Sep 1980