Cleared Traditional

K871353 - OXIMETER

K871353 is an FDA 510(k) clearance for OXIMETER, manufactured by Radiometer America, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K871353 · Radiometer America, Inc. · Anesthesiology device
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Jun 1987
Decision
63d
Days
Class 2
Risk

K871353 is an FDA 510(k) clearance for the OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on June 8, 1987 after a review of 63 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 Radiometer America, Inc. devices

FDA 510(k) Submission Details - K871353

510(k) Number K871353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1987
Decision Date June 08, 1987
Days to Decision 63 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
77d faster than avg
Panel avg: 140d · This submission: 63d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K871353.
OXIMETRY MODULE
K872626 · Marquette Electronics, Inc. · Sep 1987
PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE
K871826 · Datex Division Instrumentarium Corp. · Jun 1987
PB240 PATIENT MONITOR/PULSE OXIMETER
K871864 · Puritan Bennett Corp. · Jun 1987
SATLITE/PB251 PULSE OXIMETER
K870621 · Datex Division Instrumentarium Corp. · Mar 1987
SPACELABS MODEL 90419 PULSE OXIMETER MODULE
K864279 · Spacelabs, Inc. · Mar 1987
502 OXYGEN SATURATION MONITOR
K864613 · Criticare Systems, Inc. · Mar 1987