Cleared Traditional

K863910 - RAINCOAT

K863910 is the FDA 510(k) clearance for RAINCOAT by Artec Environmental Monitoring Division. It is a Class 1 Anesthesiology device (product code BZO) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K863910 · Artec Environmental Monitoring Division · Anesthesiology device
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Oct 1986
Decision
12d
Days
Class 1
Risk

K863910 is an FDA 510(k) clearance for the RAINCOAT. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Artec Environmental Monitoring Division (Noblesville, US). The FDA issued a Cleared decision on October 20, 1986 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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 Artec Environmental Monitoring Division devices

Submission Details

510(k) Number K863910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1986
Decision Date October 20, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 140d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZO Set, Tubing And Support, Ventilator (w Harness)

All 13
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K863910.
BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
K880637 · Baxter Healthcare Corp · Apr 1988
PORTABLE VENTILATOR PATIENT CIRCUIT
K873900 · Puritan Bennett Corp. · Oct 1987
VOLUME VENTILATOR CIRCUIT W/WATER TRAP
K834570 · Airlife, Inc. · Mar 1984
MODUFLEX NEONATAL VENTILATOR SET
K823479 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1982
INSPIRON NEONATAL VENTILATOR CIRCUIT
K821064 · C.R. Bard, Inc. · May 1982
3M VOLUME VENTIATOR CIRCUIT
K820131 · 3M Company · Jan 1982