Cleared Traditional

K961040 - BLOOD PORT CAP

K961040 is an FDA 510(k) clearance for BLOOD PORT CAP, manufactured by Dayspring Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K961040 · Dayspring Medical, Inc. · Gastroenterology & Urology device
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Jun 1996
Decision
89d
Days
Class 2
Risk

K961040 is an FDA 510(k) clearance for the BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC. 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 June 11, 1996 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dayspring Medical, Inc. devices

FDA 510(k) Submission Details - K961040

510(k) Number K961040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date June 11, 1996
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

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 96
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K961040.
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
K970708 · Terumo Medical Corp. · Dec 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933 · Baxter Healthcare Corp · Nov 1997
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
K962309 · Althin Medical AB an Affiliate of Baxter Intl · Dec 1996
FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
K952343 · National Medical Care, Medical Products Div., Inc. · Dec 1995
MCA(TM) 180 HEMODIALYZER
K945622 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
MCA(TM) 130 HEMODIALYZER
K945623 · Althin Medical AB an Affiliate of Baxter Intl · May 1995