Cleared Traditional

K855027 - PULSE OXIMETER

K855027 is an FDA 510(k) clearance for PULSE OXIMETER, manufactured by Physio-Control Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K855027 · Physio-Control Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
151d
Days
Class 2
Risk

K855027 is an FDA 510(k) clearance for the PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Physio-Control Corp. (Redmond, US). The FDA issued a Cleared decision on May 16, 1986 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Physio-Control Corp. devices

FDA 510(k) Submission Details - K855027

510(k) Number K855027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1985
Decision Date May 16, 1986
Days to Decision 151 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
11d slower than avg
Panel avg: 140d · This submission: 151d
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 476
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K855027.
BIOCHEM CO/OX 1000
K863186 · Biochem International, Inc. · Nov 1986
SENSORMEDICS OXYSHUTTLE(TM)
K862617 · Sensor Medics Corp. · Sep 1986
MODEL 8604 OXYGEN/PULSE MONITOR
K860051 · Nonin Medical, Inc. · Jun 1986
MINOLTA SM-32 OXYGEN SATURATION MONIT
K833973 · Marquest Medical Products, Inc. · May 1984
UNISTAT OXIMETER
K780625 · American Optical Corp. · Apr 1978