Cleared Traditional

K871826 - PB VIDEO DISPLAY TO PB251 PULSE OXIMETE...

K871826 is the FDA 510(k) clearance for PB VIDEO DISPLAY TO PB251 PULSE OXIMETE... by Datex Division Instrumentarium Corp.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K871826 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Jun 1987
Decision
49d
Days
Class 2
Risk

K871826 is an FDA 510(k) clearance for the PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on June 29, 1987 after a review of 49 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 Datex Division Instrumentarium Corp. devices

Submission Details

510(k) Number K871826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1987
Decision Date June 29, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
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 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K871826.
MODEL 7200A WITH PULSE OXIMETRY
K873065 · Puritan Bennett Corp. · Oct 1987
OHMEDA BIOX 3740 PULSE OXIMETER
K872772 · Ohmeda Medical · Oct 1987
OXIMETRY MODULE
K872626 · Marquette Electronics, Inc. · Sep 1987
PB240 PATIENT MONITOR/PULSE OXIMETER
K871864 · Puritan Bennett Corp. · Jun 1987
ACCUSAT
K863855 · Datascope Corp. · Jan 1987
PULSE OXIMETER
K855027 · Physio-Control Corp. · May 1986