Cleared Traditional

K832641 - WINDSOR MEDICAL MODEL 52

K832641 is an FDA 510(k) clearance for WINDSOR MEDICAL MODEL 52, 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 61-day FDA review.

K832641 · Windsor Medical, Inc. · General Hospital
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Oct 1983
Decision
61d
Days
Class 2
Risk

K832641 is an FDA 510(k) clearance for the WINDSOR MEDICAL MODEL 52. 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 October 4, 1983 after a review of 61 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Windsor Medical, Inc. devices

FDA 510(k) Submission Details - K832641

510(k) Number K832641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1983
Decision Date October 04, 1983
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
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
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