Cleared Traditional

K870626 - FREEDOM SET II WITH TRIFLEX VALVE

K870626 is the FDA 510(k) clearance for FREEDOM SET II WITH TRIFLEX VALVE by Delmed, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K870626 · Delmed, Inc. · Gastroenterology & Urology device
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Jun 1987
Decision
110d
Days
Class 2
Risk

K870626 is an FDA 510(k) clearance for the FREEDOM SET II WITH TRIFLEX VALVE. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Delmed, Inc. (Freehold, US). The FDA issued a Cleared decision on June 3, 1987 after a review of 110 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 Delmed, Inc. devices

Submission Details

510(k) Number K870626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1987
Decision Date June 03, 1987
Days to Decision 110 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 130d · This submission: 110d
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 41
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K870626.
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
K882455 · Baxter Healthcare Corp · Jul 1988
EXTENDED LIFE CAPD TRANSFER SET 5C4444
K882498 · Baxter Healthcare Corp · Jul 1988
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
K873984 · Travenol Laboratories, S.A. · Oct 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
K871049 · Abbott Laboratories · Apr 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
K871050 · Abbott Laboratories · Apr 1987
EXTERNAL Y VALVE 5C4198
K870145 · Travenol Laboratories, S.A. · Mar 1987