Cleared Traditional

K822842 - AMBULATORY MARK I

K822842 is an FDA 510(k) clearance for AMBULATORY MARK I, 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 182-day FDA review.

K822842 · Windsor Medical, Inc. · General Hospital
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Mar 1983
Decision
182d
Days
Class 2
Risk

K822842 is an FDA 510(k) clearance for the AMBULATORY MARK I. 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 March 24, 1983 after a review of 182 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 - K822842

510(k) Number K822842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1982
Decision Date March 24, 1983
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
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 K822842.
INFUSION PUMP #AS*6H
K830486 · Baxter Healthcare Corp · Apr 1983
GRASE BY DYNAMICS MS 27 SYRINGE DRIVER
K830809 · Intermedics, Inc. · Apr 1983
TREONIC IP5
K830936 · Vickers America Medical Corp. · Apr 1983
PERSONAL MEDICATION INFUSER
K830570 · Pacesetter Systems · Mar 1983
SYRINGE DRIVER MS-16
K830423 · Intermedics, Inc. · Mar 1983
HARVARD APPARATUS INTERMITTENT INFUSION
K830102 · C.R. Bard, Inc. · Feb 1983