Cleared Traditional

K862617 - SENSORMEDICS OXYSHUTTLE(TM)

K862617 is an FDA 510(k) clearance for SENSORMEDICS OXYSHUTTLE(TM), manufactured by Sensor Medics Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K862617 · Sensor Medics Corp. · Anesthesiology device
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Sep 1986
Decision
79d
Days
Class 2
Risk

K862617 is an FDA 510(k) clearance for the SENSORMEDICS OXYSHUTTLE(TM). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Sensor Medics Corp. (Anaheim, US). The FDA issued a Cleared decision on September 26, 1986 after a review of 79 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 Sensor Medics Corp. devices

FDA 510(k) Submission Details - K862617

510(k) Number K862617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1986
Decision Date September 26, 1986
Days to Decision 79 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
61d faster than avg
Panel avg: 140d · This submission: 79d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K862617.
MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.
K863918 · Marquest Medical Products, Inc. · Jan 1987
ACCUSAT
K863855 · Datascope Corp. · Jan 1987
BIOCHEM CO/OX 1000
K863186 · Biochem International, Inc. · Nov 1986
MODEL 8604 OXYGEN/PULSE MONITOR
K860051 · Nonin Medical, Inc. · Jun 1986
PULSE OXIMETER
K855027 · Physio-Control Corp. · May 1986
MINOLTA SM-32 OXYGEN SATURATION MONIT
K833973 · Marquest Medical Products, Inc. · May 1984