Cleared Traditional

K890299 - KONTRON PULSE OXIMETER 7840

K890299 is an FDA 510(k) clearance for KONTRON PULSE OXIMETER 7840, 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 42-day FDA review.

K890299 · Kontron Instruments, Inc. · Anesthesiology device
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Mar 1989
Decision
42d
Days
Class 2
Risk

K890299 is an FDA 510(k) clearance for the KONTRON PULSE OXIMETER 7840. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on March 2, 1989 after a review of 42 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 - K890299

510(k) Number K890299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1989
Decision Date March 02, 1989
Days to Decision 42 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
98d faster than avg
Panel avg: 140d · This submission: 42d
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 K890299.
OXIMETER
K893587 · Radiometer America, Inc. · Sep 1989
TYPE 9266 SAO2 SYSTEM ATHENA
K884121 · S & W Medico Teknik · Apr 1989
SATLITE TRANS PORTABLE PULSE OXIMETER
K890753 · Datex Division Instrumentarium Corp. · Mar 1989
CNS-8200A CENTRAL NURSES STATION
K884050 · Nihon Kohden America, Inc. · Feb 1989
AL-800PA PULSE OXIMETER MODULE
K884536 · Nihon Kohden America, Inc. · Feb 1989
MODEL 8700 PULSE OXIMETER
K890033 · Nonin Medical, Inc. · Feb 1989