Cleared Traditional

K812737 - RAIN-X

K812737 is an FDA 510(k) clearance for RAIN-X, manufactured by Nova-Ventrx. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K812737 · Nova-Ventrx · Anesthesiology device
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Oct 1981
Decision
24d
Days
Class 1
Risk

K812737 is an FDA 510(k) clearance for the RAIN-X. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Nova-Ventrx (Mchenry, US). The FDA issued a Cleared decision on October 23, 1981 after a review of 24 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 Nova-Ventrx devices

FDA 510(k) Submission Details - K812737

510(k) Number K812737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1981
Decision Date October 23, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

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 53
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K812737.
INSPIRON NEONATAL VENTILATOR CIRCUIT
K821064 · C.R. Bard, Inc. · May 1982
3M VOLUME VENTIATOR CIRCUIT
K820131 · 3M Company · Jan 1982
PEDIATRIC VENTILATOR CIRCUIT 2C7131
K813155 · Travenol Laboratories, S.A. · Dec 1981
VENTILATOR CIRCUIT
K812774 · Hudson Oxygen Therapy Sales Co. · Oct 1981
CAM-10 RESPIRATORY HOSE ASSEMBLIES
K801859 · Lifecare Services, Inc. · Sep 1980
CIRCAPAK
K792268 · Respiratory Care, Inc. · Nov 1979