Cleared Traditional

K912352 - PEACE MODEL 100 CUFF MONITOR

K912352 is the FDA 510(k) clearance for PEACE MODEL 100 CUFF MONITOR by Peace Medical, Inc.. It is a Class 2 Anesthesiology device (product code BSK) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K912352 · Peace Medical, Inc. · Anesthesiology device
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Aug 1991
Decision
66d
Days
Class 2
Risk

K912352 is an FDA 510(k) clearance for the PEACE MODEL 100 CUFF MONITOR. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Peace Medical, Inc. (Orange, US). The FDA issued a Cleared decision on August 2, 1991 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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 Peace Medical, Inc. devices

Submission Details

510(k) Number K912352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1991
Decision Date August 02, 1991
Days to Decision 66 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
74d faster than avg
Panel avg: 140d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
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 - BSK Cuff, Tracheal Tube, Inflatable

All 12
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K912352.
Accucuff Cuff Pressure Indicator
K182548 · Tianjin Medis Medical Device Co., Ltd. · Jan 2019
AG 100s
K180991 · Hospitech Respiration , Ltd. · Oct 2018
VORTRAN Cuff Inflator (VCI)
K173914 · Vortran Medical Technology 1, Inc. · May 2018
RESPIRONICS PR VALVE
K833327 · Respironics, Inc. · Nov 1983
SHILEY PRESSURE RELIEF ADAPTER PRA
K792265 · Shiley, Inc. · Nov 1979