Cleared Traditional

K863855 - ACCUSAT

K863855 is an FDA 510(k) clearance for ACCUSAT, manufactured by Datascope Corp.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K863855

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.

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 547
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K863855.
502 OXYGEN SATURATION MONITOR
K864613 · Criticare Systems, Inc. · Mar 1987
BIOCHEM MICROSPAN 1040 OXIMETER
K870163 · Biochem International, Inc. · Mar 1987
MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.
K863918 · Marquest Medical Products, Inc. · Jan 1987
NELLCOR MVP, MODEL N-1000
K862812 · Nellcor, Inc. · Dec 1986
NELLCOR N-200 (PULSE OXIMETER)
K863784 · Nellcor, Inc. · Nov 1986
BIOCHEM CO/OX 1000
K863186 · Biochem International, Inc. · Nov 1986