Cleared Traditional

K832352 - 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE

K832352 is the FDA 510(k) clearance for 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE by Parke-Davis Co.. It is a Class 2 Anesthesiology device (product code BSO) cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K832352 · Parke-Davis Co. · Anesthesiology device
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Jan 1984
Decision
182d
Days
Class 2
Risk

K832352 is an FDA 510(k) clearance for the 3-DAY RELEASE OF ETHYLENE OXIDE DEVICE. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Parke-Davis Co. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Parke-Davis Co. devices

Submission Details

510(k) Number K832352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1983
Decision Date January 13, 1984
Days to Decision 182 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 140d · This submission: 182d
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 27
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K832352.
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