Cleared Traditional

K896544 - MD2 PERSONAL INFUSION SYSTEM

K896544 is an FDA 510(k) clearance for MD2 PERSONAL INFUSION SYSTEM, manufactured by Norfolk Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K896544 · Norfolk Medical Products, Inc. · General Hospital
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May 1990
Decision
166d
Days
Class 2
Risk

K896544 is an FDA 510(k) clearance for the MD2 PERSONAL INFUSION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Norfolk Medical Products, Inc. (Skokie, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 166 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 Norfolk Medical Products, Inc. devices

FDA 510(k) Submission Details - K896544

510(k) Number K896544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1989
Decision Date May 02, 1990
Days to Decision 166 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
37d slower than avg
Panel avg: 129d · This submission: 166d
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 563
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K896544.
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
FLO-GARD 6300 BLOOD PUMPING INDICATION
K900699 · Baxter Healthcare Corp · Apr 1990
AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
K900204 · 3M Company · Apr 1990
LIFECARE(R) 175 INFUSER
K900057 · Abbott Laboratories · Mar 1990