Cleared Traditional

K982134 - DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851

K982134 is an FDA 510(k) clearance for DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES..., manufactured by Dynamic Technology Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K982134 · Dynamic Technology Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
301d
Days
Class 2
Risk

K982134 is an FDA 510(k) clearance for the DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Dynamic Technology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on April 14, 1999 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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. Elevated predicate reliance profile. 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 - K982134

510(k) Number K982134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date April 14, 1999
Days to Decision 301 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 131d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 315
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K982134.
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
K992275 · Fresenius USA, Inc. · Aug 1999
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
K991520 · Fresenius Medical Care North America · Jul 1999
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
K982413 · Gambro Healthcare · Apr 1999
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
K982414 · Gambro Healthcare · Mar 1999
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)
K980386 · Gambro Healthcare · Feb 1999
HEMOCOR HPH 700 HEMOCONCENTRATOR
K983085 · Minntech Corp. · Nov 1998