Cleared Traditional

K875031 - OXYGEN/PULSE MONITOR

K875031 is an FDA 510(k) clearance for OXYGEN/PULSE MONITOR, manufactured by Healthdyne, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K875031 · Healthdyne, Inc. · Anesthesiology device
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Feb 1988
Decision
67d
Days
Class 2
Risk

K875031 is an FDA 510(k) clearance for the OXYGEN/PULSE MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Marietta, US). The FDA issued a Cleared decision on February 12, 1988 after a review of 67 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 Healthdyne, Inc. devices

FDA 510(k) Submission Details - K875031

510(k) Number K875031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date February 12, 1988
Days to Decision 67 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
73d faster than avg
Panel avg: 140d · This submission: 67d
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 502
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K875031.
502-US PULSE OXIMETER
K875298 · Criticare Systems, Inc. · Mar 1988
DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
K874442 · Critikon Company, LLC · Feb 1988
MODEL 8800 CARDIORESPIRATORY OXIMETER
K874947 · Nonin Medical, Inc. · Feb 1988
OHMEDA 4700 OXICAP MONITOR
K873199 · Ohmeda Medical · Feb 1988
CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104
K873859 · Datex Division Instrumentarium Corp. · Dec 1987
OHMEDA BIOX 3760 PULSE OXIMETER
K874104 · Ohmeda Medical · Dec 1987