Cleared Traditional

BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL (K961039) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961039 · Dayspring Medical, Inc. · Gastroenterology & Urology device
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Sep 1996
Decision
182d
Days
Class 2
Risk

K961039 is an FDA 510(k) clearance for the BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABL.... Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Dayspring Medical, Inc. (Boulder, US). The FDA issued a Cleared decision on September 12, 1996 after a review of 182 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Dayspring Medical, Inc. devices

Submission Details

510(k) Number K961039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date September 12, 1996
Days to Decision 182 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
52d slower than avg
Panel avg: 130d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJI Dialyzer, Capillary, Hollow Fiber
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 130
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K961039.
Hemoflow F3 and F4 Dialyzers
K190459 · Fresenius Medical Care Renal Therapies Group, LLC · Aug 2019
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658 · Baxter Healthcare Corp · May 1998
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933 · Baxter Healthcare Corp · Nov 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454 · Baxter Healthcare Corp · Apr 1995
BAXTER CA DIALYZER
K926567 · Baxter Healthcare Corp · Jan 1995
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
K905228 · Baxter Healthcare Corp · Dec 1990