Cleared Traditional

K935582 - TUBE, INHALER OXYGEN

K935582 is an FDA 510(k) clearance for TUBE, manufactured by Puritas Health Care, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K935582 · Puritas Health Care, Inc. · Anesthesiology device
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Jan 1994
Decision
57d
Days
Class 1
Risk

K935582 is an FDA 510(k) clearance for the TUBE, INHALER OXYGEN. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on January 14, 1994 after a review of 57 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 Puritas Health Care, Inc. devices

FDA 510(k) Submission Details - K935582

510(k) Number K935582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date January 14, 1994
Days to Decision 57 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 140d · This submission: 57d
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 52
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K935582.
PRIMA, INC. CORRUGATED TUBING
K944531 · Prima, Inc. · Dec 1994
VENTILATOR HOSE
K942569 · Med-Plastics Intl., Inc. · Jun 1994
VOLUME VENTILATOR
K942572 · Med-Plastics Intl., Inc. · Jun 1994
STAR BREATHING CIRCUITS
K934753 · Infrasonics Corp. · Oct 1993
PRECISION MED PRODUCTS LTD. VENTILATOR HOSE
K932706 · Precision Med Products, Ltd. · Jul 1993
VOLUME VENTILATORS
K932560 · Life Shield Healthcare Products, Inc. · Jul 1993