Cleared Traditional

K896422 - BURRON AMBULATORY DRUG DELIVERY SYSTEM

K896422 is an FDA 510(k) clearance for BURRON AMBULATORY DRUG DELIVERY SYSTEM, manufactured by Burron Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K896422 · Burron Medical, Inc. · General Hospital
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May 1990
Decision
182d
Days
Class 2
Risk

K896422 is an FDA 510(k) clearance for the BURRON AMBULATORY DRUG DELIVERY SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Burron Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 9, 1990 after a review of 182 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 Burron Medical, Inc. devices

FDA 510(k) Submission Details - K896422

510(k) Number K896422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1989
Decision Date May 09, 1990
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 608
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K896422.
PANCRETEC I.V. MODEL 5000 INFUSER
K895867 · Abbott Laboratories · Jun 1990
MODIFIED MINIMED III INFUSION PUMP
K895436 · Medtronic Minimed · May 1990
LOCKBOX
K900888 · Pharmacia Deltec, Inc. · May 1990
MD2 PERSONAL INFUSION SYSTEM
K896544 · Norfolk Medical Products, Inc. · May 1990
FLO-GARD 6300 BLOOD PUMPING INDICATION
K900699 · Baxter Healthcare Corp · Apr 1990
AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
K900204 · 3M Company · Apr 1990