Cleared Traditional

K853664 - HEPARIN MICRO-INFUSOR

K853664 is the FDA 510(k) clearance for HEPARIN MICRO-INFUSOR by Y. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K853664 · Y · General Hospital
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Mar 1986
Decision
196d
Days
Class 2
Risk

K853664 is an FDA 510(k) clearance for the HEPARIN MICRO-INFUSOR. 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 18, 1986 after a review of 196 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 K853664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1985
Decision Date March 18, 1986
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
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 K853664.
IV7200 AND IV7400 INFUSION PUMP
K860694 · Valleylab, Inc. · Apr 1986
FLO-GARD 6200 VOLUMETRIC INFUSION PUMP
K860162 · Travenol Laboratories, S.A. · Apr 1986
MODEL 900 INFUSION PUMP
K860229 · C.R. Bard, Inc. · Apr 1986
LIFEPORT AMBULATORY INFUSION PUMP
K854318 · Strato Medical Corp. · Mar 1986
ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY
K852168 · Y · Mar 1986
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
K853629 · C.R. Bard, Inc. · Jan 1986