Cleared Traditional

K061764 - MEDIBYTE, MODEL MP8

K061764 is an FDA 510(k) clearance for MEDIBYTE, manufactured by Braebon Medical Corp.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K061764 · Braebon Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
76d
Days
Class 2
Risk

K061764 is an FDA 510(k) clearance for the MEDIBYTE, MODEL MP8. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Braebon Medical Corp. (Carp, Ontario, CA). The FDA issued a Cleared decision on September 6, 2006 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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.

FDA 510(k) Submission Details - K061764

510(k) Number K061764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2006
Decision Date September 06, 2006
Days to Decision 76 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
64d faster than avg
Panel avg: 140d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 162
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K061764.
SOMNOSCREEN
K060708 · Somnomedics GmbH & Co. KG · Jan 2007
CADWELL EASYNET NASAL PRESSURE MODULE
K061705 · Cadwell Laboratories, Inc. · Nov 2006
SANDMAN POCKET
K061996 · Eb Neuro S.P.A. · Oct 2006
APNEALINK, MODEL 22302
K061405 · Resmed Germany, Inc. · Jul 2006
STARDUST II
K052573 · Respironics, Inc. · Dec 2005
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K051313 · Salter Labs · Sep 2005