Cleared Traditional

MODEL 78850 OXYGEN MONITOR (K812167) - FDA 510(k) Clearance

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

K812167 · Hewlett-Packard Co. · Anesthesiology device
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Aug 1981
Decision
32d
Days
Class 2
Risk

K812167 is an FDA 510(k) clearance for the MODEL 78850 OXYGEN MONITOR. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2500 - 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K812167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1981
Decision Date August 31, 1981
Days to Decision 32 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
107d faster than avg
Panel avg: 139d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2500
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 - KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K812167.
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
K925910 · Hewlett-Packard Co. · Jul 1993
IL 301 PORTABLE TRANSCUT. OXYGEN MONI
K834057 · Instrumentation Laboratory CO · Feb 1984
IL 301 TRANSCUTANEOUS OXYGEN MONITOR
K822328 · Instrumentation Laboratory CO · Sep 1982
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS
K810999 · Cordis Corp. · Jun 1981