Cleared Traditional

K933619 - PD-PAK

K933619 is an FDA 510(k) clearance for PD-PAK, manufactured by General Medical Mfg. Co.. The device is a Class 2 Gastroenterology & Urology device with product code MLW cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K933619 · General Medical Mfg. Co. · Gastroenterology & Urology device
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Feb 1994
Decision
218d
Days
Class 2
Risk

K933619 is an FDA 510(k) clearance for the PD-PAK. Classified as Warmer, Peritoneal Dialysate (product code MLW), Class II - Special Controls.

Submitted by General Medical Mfg. Co. (Richmond, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 218 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 General Medical Mfg. Co. devices

FDA 510(k) Submission Details - K933619

510(k) Number K933619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1993
Decision Date February 22, 1994
Days to Decision 218 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 130d · This submission: 218d
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.