Cleared Traditional

K863855 - ACCUSAT

K863855 is the FDA 510(k) clearance for ACCUSAT by Datascope Corp.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K863855 · Datascope Corp. · Anesthesiology device
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Jan 1987
Decision
96d
Days
Class 2
Risk

K863855 is an FDA 510(k) clearance for the ACCUSAT. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 96 days - within the typical 510(k) review window.

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 Datascope Corp. devices

Submission Details

510(k) Number K863855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1986
Decision Date January 06, 1987
Days to Decision 96 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
44d faster than avg
Panel avg: 140d · This submission: 96d
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 337
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K863855.
OXIMETER
K871353 · Radiometer America, Inc. · Jun 1987
SATLITE/PB251 PULSE OXIMETER
K870621 · Datex Division Instrumentarium Corp. · Mar 1987
SPACELABS MODEL 90419 PULSE OXIMETER MODULE
K864279 · Spacelabs, Inc. · Mar 1987
MODEL 8604 OXYGEN/PULSE MONITOR
K860051 · Nonin Medical, Inc. · Jun 1986
PULSE OXIMETER
K855027 · Physio-Control Corp. · May 1986