Cleared Traditional

AMBULATORY MARK III INFUSION DEVICE (K830656) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830656 · Windsor Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 236
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
PROMINJET PUMP
K832120 · Abbott Laboratories · Aug 1983
FLO-GARD 6100 VOLUMETRIC INFUSION PUMP
K831258 · Travenol Laboratories, S.A. · Jun 1983