Cleared Traditional

KONTRON PULSE OXIMETER 7840 (K873624) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K873624 · Kontron Instruments, Inc. · Anesthesiology device
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Oct 1988
Decision
407d
Days
Class 2
Risk

K873624 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 October 19, 1988 after a review of 407 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Kontron Instruments, Inc. devices

Submission Details

510(k) Number K873624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1987
Decision Date October 19, 1988
Days to Decision 407 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 139d · This submission: 407d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 159
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K873624.
AL-800PA PULSE OXIMETER MODULE
K884536 · Nihon Kohden America, Inc. · Feb 1989
SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER
K884329 · Baxter Healthcare Corp · Dec 1988
OLV 1100
K881307 · Nihon Kohden America, Inc. · Nov 1988
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
K883297 · Hewlett-Packard Co. · Oct 1988
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
K881136 · Hewlett-Packard Co. · May 1988