Cleared Traditional

K895425 - MINIMON 7137B PATIENT MONITOR

K895425 is an FDA 510(k) clearance for MINIMON 7137B PATIENT MONITOR, manufactured by Kontron Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K895425 · Kontron Instruments, Inc. · Anesthesiology device
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Sep 1989
Decision
19d
Days
Class 2
Risk

K895425 is an FDA 510(k) clearance for the MINIMON 7137B PATIENT MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K895425

510(k) Number K895425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1989
Decision Date September 26, 1989
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 447
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K895425.
MODEL 8500 HAND HELD PULSE OXIMETER
K893221 · Nonin Medical, Inc. · Feb 1990
NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
K893643 · Novametrix Medical Systems, Inc. · Oct 1989
ESCORT PULSE OXIMETRY OPTION
K892120 · Medical Data Electronics · Sep 1989
CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE
K893867 · Spacelabs, Inc. · Sep 1989
OXIMETER
K893587 · Radiometer America, Inc. · Sep 1989
TYPE 9266 SAO2 SYSTEM ATHENA
K884121 · S & W Medico Teknik · Apr 1989