Cleared Traditional

K944531 - PRIMA, INC. CORRUGATED TUBING

K944531 is an FDA 510(k) clearance for PRIMA, manufactured by Prima, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K944531 · Prima, Inc. · Anesthesiology device
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Dec 1994
Decision
78d
Days
Class 1
Risk

K944531 is an FDA 510(k) clearance for the PRIMA, INC. CORRUGATED TUBING. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Prima, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 78 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 Prima, Inc. devices

FDA 510(k) Submission Details - K944531

510(k) Number K944531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1994
Decision Date December 02, 1994
Days to Decision 78 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
62d faster than avg
Panel avg: 140d · This submission: 78d
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 K944531.
PRIMA BREATHING BAGS
K952011 · Prima, Inc. · May 1995
PRIMA CUSTOM ANESTESIA CIRCUIT
K952012 · Prima, Inc. · May 1995
PRIMA VOLUMN VENTILATORSS
K952022 · Prima, Inc. · May 1995
VENTILATOR HOSE
K942569 · Med-Plastics Intl., Inc. · Jun 1994
VOLUME VENTILATOR
K942572 · Med-Plastics Intl., Inc. · Jun 1994
TUBE, INHALER OXYGEN
K935582 · Puritas Health Care, Inc. · Jan 1994