Cleared Traditional

K020542 - DAYTRIPPER DIALYSATE WARMER

K020542 is an FDA 510(k) clearance for DAYTRIPPER DIALYSATE WARMER, manufactured by Stickman Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MLW cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K020542 · Stickman Industries, Inc. · Gastroenterology & Urology device
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Sep 2002
Decision
220d
Days
Class 2
Risk

K020542 is an FDA 510(k) clearance for the DAYTRIPPER DIALYSATE WARMER. Classified as Warmer, Peritoneal Dialysate (product code MLW), Class II - Special Controls.

Submitted by Stickman Industries, Inc. (Ottawa, Ontario, CA). The FDA issued a Cleared decision on September 27, 2002 after a review of 220 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stickman Industries, Inc. devices

FDA 510(k) Submission Details - K020542

510(k) Number K020542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2002
Decision Date September 27, 2002
Days to Decision 220 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 131d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLW Device Classification - Class 2, Special Controls

Product Code MLW Warmer, Peritoneal Dialysate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - MLW Warmer, Peritoneal Dialysate

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