Cleared Traditional

K973291 - DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES

K973291 is an FDA 510(k) clearance for DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES, manufactured by Dynamic Technology Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K973291 · Dynamic Technology Corp. · Gastroenterology & Urology device
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Dec 1997
Decision
108d
Days
Class 2
Risk

K973291 is an FDA 510(k) clearance for the DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Dynamic Technology Corp. (Plano, US). The FDA issued a Cleared decision on December 19, 1997 after a review of 108 days - within the typical 510(k) review window.

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 Dynamic Technology Corp. devices

FDA 510(k) Submission Details - K973291

510(k) Number K973291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1997
Decision Date December 19, 1997
Days to Decision 108 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 130d · This submission: 108d
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 K973291.
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
K002761 · Fresenius Medical Care North America · Dec 2000
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658 · Baxter Healthcare Corp · May 1998
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