Cleared Traditional

K830656 - AMBULATORY MARK III INFUSION DEVICE

K830656 is an FDA 510(k) clearance for AMBULATORY MARK III INFUSION DEVICE, manufactured by Windsor Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K830656 · Windsor Medical, Inc. · General Hospital
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Aug 1983
Decision
167d
Days
Class 2
Risk

K830656 is an FDA 510(k) clearance for the AMBULATORY MARK III INFUSION DEVICE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Windsor Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1983 after a review of 167 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 Windsor Medical, Inc. devices

FDA 510(k) Submission Details - K830656

510(k) Number K830656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1983
Decision Date August 16, 1983
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
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 620
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K830656.
PUMPETTE AS8P-INFUSION PUMP
K831534 · Travenol Laboratories, S.A. · Sep 1983
LIFECARE MICRO PUMP
K832289 · Abbott Laboratories · Sep 1983
GRASEBY DYNAMICS MS302 SYRINGE DRIVER
K832410 · Intermedics, Inc. · Sep 1983
FLO-GARD 8500 MICROINFUSION PUMP
K832166 · Travenol Laboratories, S.A. · Aug 1983
CORPAK VTR 300 ENTERNAL PUMP
K832167 · Corpak Co. · Aug 1983
SIMPLICITY PLUS
K831761 · Critikon Company, LLC · Aug 1983