Cleared Traditional

K944512 - TRUZONE PFM DISPOSABLE MOUTHPIECE

K944512 is an FDA 510(k) clearance for TRUZONE PFM DISPOSABLE MOUTHPIECE, manufactured by Monaghan Medical Corp.. The device is a Class 1 Anesthesiology device with product code BYP cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K944512 · Monaghan Medical Corp. · Anesthesiology device
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Nov 1994
Decision
48d
Days
Class 1
Risk

K944512 is an FDA 510(k) clearance for the TRUZONE PFM DISPOSABLE MOUTHPIECE. Classified as Mouthpiece, Breathing (product code BYP), Class I - General Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on November 2, 1994 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5620 - 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 Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K944512

510(k) Number K944512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1994
Decision Date November 02, 1994
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

BYP Device Classification - Class 1, General Controls

Product Code BYP Mouthpiece, Breathing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5620
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 - BYP Mouthpiece, Breathing

All 14
Devices cleared under the same product code (BYP) and FDA review panel - the closest regulatory comparables to K944512.
AEROCHAMBER
K872037 · Monaghan Medical Corp. · Jul 1987
MP-4400 MOUTHPIECE-FLANGE SEAL
K862788 · Medipart Jerry Alexander · Aug 1986
MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410
K853572 · Medipart Jerry Alexander · Oct 1985
MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411
K853574 · Medipart Jerry Alexander · Oct 1985
MEDIPART MOUTHPIECE MP-1010
K853575 · Medipart Jerry Alexander · Oct 1985
E-Z-GUARD MOUTHPIECE
K853402 · E-Z-Em, Inc. · Oct 1985