Cleared Traditional

K854265 - SIMULATOR

K854265 is an FDA 510(k) clearance for SIMULATOR, manufactured by Cygnus of South Florida, Inc.. The device is a Class 1 General Hospital device with product code JQP cleared through the Traditional 510(k) pathway after a 146-day FDA review.

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

FDA 510(k) Submission Details - K854265

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.

JQP Device Classification - Class 1, General Controls

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 56
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K854265.
GLUCOFACTS DATA PRINTER
K861779 · Miles Laboratories, Inc. · Aug 1986
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K861778 · Miles Laboratories, Inc. · Jul 1986
DIRECT READOUT MODULE ACCESSORY
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
GELSCAN SOFTWARE 2190
K834490 · Lkb Instruments, Inc. · May 1984