Cleared Traditional

K852175 - PATIENT DATA SYSTEMS CVA

K852175 is an FDA 510(k) clearance for PATIENT DATA SYSTEMS CVA, manufactured by Patient Data Systems. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K852175 · Patient Data Systems · Anesthesiology device
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Sep 1985
Decision
109d
Days
Class 2
Risk

K852175 is an FDA 510(k) clearance for the PATIENT DATA SYSTEMS CVA. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Patient Data Systems (Weston, US). The FDA issued a Cleared decision on September 6, 1985 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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.

FDA 510(k) Submission Details - K852175

510(k) Number K852175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date September 06, 1985
Days to Decision 109 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 140d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 163
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K852175.
NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
K861170 · Draeger Medical, Inc. · Apr 1986
NARKOMED 3 ANESTHESIA SYSTEM
K853435 · Draeger Medical, Inc. · Jan 1986
ARI STANDARD ANESTHESIA RECORD
K854213 · Agilent Technologies, Inc. · Dec 1985
OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K850648 · Ohmeda Medical · Jul 1985
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
K844849 · Ohmeda Medical · May 1985
BOOM ARM
K851621 · Draeger Medical, Inc. · May 1985
K852175 · PATIENT DATA SYSTEMS CVA
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