Cleared Traditional

WINDSOR MEDICAL VARIOUS MODELS (K832606) - FDA 510(k) Clearance

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

K832606 · Windsor Medical, Inc. · General Hospital
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Nov 1983
Decision
118d
Days
Class 2
Risk

K832606 is an FDA 510(k) clearance for the WINDSOR MEDICAL VARIOUS MODELS. 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 November 29, 1983 after a review of 118 days - within the typical 510(k) review window.

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 K832606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1983
Decision Date November 29, 1983
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
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 K832606.
GILLETTE SABRE SYRINGE
K833655 · Intermedics, Inc. · Dec 1983
FLO-GARD 8100 INFUSION PUMP
K833958 · Travenol Laboratories, S.A. · Dec 1983
VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY
K832285 · Travenol Laboratories, S.A. · Dec 1983
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