Cleared Traditional

K945567 - QC CAP

K945567 is the FDA 510(k) clearance for QC CAP by Medionics International, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K945567 · Medionics International, Inc. · Gastroenterology & Urology device
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Feb 1995
Decision
133d
Days
Class 2
Risk

K945567 is an FDA 510(k) clearance for the QC CAP. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Medionics International, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on February 7, 1995 after a review of 133 days - within the typical 510(k) review window.

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 Medionics International, Inc. devices

Submission Details

510(k) Number K945567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1994
Decision Date February 07, 1995
Days to Decision 133 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
3d slower than avg
Panel avg: 130d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
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 - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 72
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K945567.
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
K031676 · Baxter Healthcare Corp · Nov 2003
HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE
K972579 · Baxter Healthcare Corp · Oct 1997
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825 · Baxter Healthcare Corp · Aug 1996
RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
K930843 · National Medical Care, Medical Products Div., Inc. · Aug 1994
ABBOTT SMART CAP
K921818 · Abbott Laboratories · Mar 1994
BAXTER APD 12' EXTENSION LINE
K925403 · Baxter Healthcare Corp · Feb 1994