Cleared Traditional

K853629 - BARD HARVARD CHRONOFUSOR TIME-DOSE SYRI...

K853629 is the FDA 510(k) clearance for BARD HARVARD CHRONOFUSOR TIME-DOSE SYRI... by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K853629 · C.R. Bard, Inc. · General Hospital
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Jan 1986
Decision
150d
Days
Class 2
Risk

K853629 is an FDA 510(k) clearance for the BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on January 27, 1986 after a review of 150 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K853629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1985
Decision Date January 27, 1986
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K853629.
HEPARIN MICRO-INFUSOR
K853664 · Y · Mar 1986
LIFEPORT AMBULATORY INFUSION PUMP
K854318 · Strato Medical Corp. · Mar 1986
ELECTRONIC COMMUNICATION SYS ACCESSORY FOR GRAVITY
K852168 · Y · Mar 1986
MP0400 ADULT, PERISTALIC INFUSION PUMP
K853814 · Medex, Inc. · Jan 1986
THE TRAVENOL 5 ML/HR INFUSOR
K853881 · Travenol Laboratories, S.A. · Dec 1985
NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8
K853134 · Erika, Inc. · Nov 1985