Cleared Traditional

K944531 - PRIMA

K944531 is the FDA 510(k) clearance for PRIMA by Prima, Inc.. It is a Class 1 Anesthesiology device (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

Submission Details

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
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
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 K944531.
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