Cleared Traditional

SIMULATOR (K854265) - FDA 510(k) Clearance

Class I General Hospital device.

K854265 · Cygnus of South Florida, Inc. · General Hospital
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Mar 1986
Decision
146d
Days
Class 1
Risk

K854265 is an FDA 510(k) clearance for the SIMULATOR. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Cygnus of South Florida, Inc. (Hollywood, US). The FDA issued a Cleared decision on March 18, 1986 after a review of 146 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 862.2100 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cygnus of South Florida, Inc. devices

Submission Details

510(k) Number K854265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1985
Decision Date March 18, 1986
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 129d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQP Calculator/data Processing Module, For Clinical Use

All 30
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K854265.
GLUCOFACTS DATA PRINTER
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K861778 · Miles Laboratories, Inc. · Jul 1986
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K861412 · E.I. Dupont DE Nemours & Co., Inc. · May 1986
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659 · Syva Co. · Apr 1985
CLINIFACTS 10 DATA MANAGEMENT SYSTEM
K844907 · Miles Laboratories, Inc. · Jan 1985
ACLAIM-QAP IBM PERSONAL COMPUTER EDT
K833353 · American Dade · Dec 1983