Cleared Traditional

K852168 - ELECTRONIC COMMUNICATION SYS ACCESSORY ...

K852168 is the FDA 510(k) clearance for ELECTRONIC COMMUNICATION SYS ACCESSORY ... by Y. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K852168 · Y · General Hospital
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Mar 1986
Decision
296d
Days
Class 2
Risk

K852168 is an FDA 510(k) clearance for the ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 296 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Y devices

Submission Details

510(k) Number K852168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date March 12, 1986
Days to Decision 296 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 129d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 447
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K852168.
MODEL 900 INFUSION PUMP
K860229 · C.R. Bard, Inc. · Apr 1986
HEPARIN MICRO-INFUSOR
K853664 · Y · Mar 1986
LIFEPORT AMBULATORY INFUSION PUMP
K854318 · Strato Medical Corp. · Mar 1986
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
K853629 · C.R. Bard, Inc. · Jan 1986
MP0400 ADULT, PERISTALIC INFUSION PUMP
K853814 · Medex, Inc. · Jan 1986
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · Travenol Laboratories, S.A. · Dec 1985