510(k) Report

510(k) · Cleared

Cleared

Dynamic Hollow Fiber Dialyzer DS-Series Model as-851

K982134510(k) TraditionalCleared Apr 14, 1999301-day reviewClass II21 CFR 876.5860

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dynamic Technology Corp. · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

Cleared on Apr 14, 1999 as substantially equivalent to K923727 (Minntech Corp., 1994) and 3 other predicates after a 301-day review. Its family tree reaches back 2 generations to 1987.

Decided
Apr 14, 1999
Review
301 days
Class
Class II
Product code
KDI
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K864831 (1987). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1991: 1 other ancestor1987: 1 other ancestorK864831 · Cobe Centrysystem 145E,160E,175E,190E Dialyzers · Cobe Laboratories, Inc. · 1987K973291 · Dynamic Hollow Fiber Dialyzer DC-Series · Dynamic Technology Corp. · 19971985199019952000
Other ancestors, by generation 1 generation back: 3 other ancestors K973291 · Dynamic Hollow Fiber Dialyzer DC-Series · Dynamic Technology Corp. · 1997K864831 · Cobe Centrysystem 145E,160E,175E,190E Dialyzers · Cobe Laboratories, Inc. · 19870
  1. Root · 2 generations backK864831 Cobe Centrysystem 145E,160E,175E,190E DialyzersCobe Laboratories, Inc. · 1987
  2. 1 generation backK973291 Dynamic Hollow Fiber Dialyzer DC-SeriesDynamic Technology Corp. · 1997
  3. This deviceK982134 Dynamic Hollow Fiber Dialyzer DS-Series Model as-851Dynamic Technology Corp. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K864831Cobe Centrysystem 145E,160E,175E,190E DialyzersCobe Laboratories, Inc.1987—
−1K973291Dynamic Hollow Fiber Dialyzer DC-SeriesDynamic Technology Corp.1997—
0 (this device)K982134Dynamic Hollow Fiber Dialyzer DS-Series Model as-851Dynamic Technology Corp.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
199410
FIG. 1 — Lineage of K982134, 1987–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KDI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KDI device

  1. #1 K243874 FX CorAL 60 (F00012969); FX CorAL 80…score 18.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K923727Primus Hollow Fiber Dialyzer Mod. 1000, 1350, 2000
Summary page 1
…nd a wall thickness of 40 microns. The fibers used in this device which is substantially equivalent to the fibers utilized in the Minntech Primus™ Hollow Fiber Dialyzer (K923727), Fresenius Hemoflow HF Dialyzer (K870724), and Minntech Renaflo™ HDF Hemodiafilter (K910236), which have been previously approve…
Minntech Corp.1994—
*K870724Fresenius Hemoflow F60 and F80
Summary page 1
…ers used in this device which is substantially equivalent to the fibers utilized in the Minntech Primus™ Hollow Fiber Dialyzer (K923727), Fresenius Hemoflow HF Dialyzer (K870724), and Minntech Renaflo™ HDF Hemodiafilter (K910236), which have been previously approved under a 510(k) Notification. The wall th…
Seratronics, Inc.1987—
*K910236Renaflo HDF 1350 Hemodiafilter
Summary page 1
…valent to the fibers utilized in the Minntech Primus™ Hollow Fiber Dialyzer (K923727), Fresenius Hemoflow HF Dialyzer (K870724), and Minntech Renaflo™ HDF Hemodiafilter (K910236), which have been previously approved under a 510(k) Notification. The wall thickness of the hollow fibers in Minntech Primus™ Ho…
Minntech Corp.1991—
*K973291Dynamic Hollow Fiber Dialyzer DC-Series
Summary page 2
…peration to the Minntech Primus™ Hollow Fiber Dialyzer, Fresenius Hemoflow HF Dialyzer, Minntech Renaflo™ HDF Hemodiafilter, and DYNAMIC Hollow Fiber Dialyzer DC-Series (K973291), which have been previously approved for marketing in the United States under 510(K) Notification. Intended Use The DYNAMIC Ho…
Dynamic Technology Corp.1997—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
  • None of the 5 ancestors has a recall.

How does its category compare?

All KDI devices

KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDI

9in 2025

2007: 112008: 62009: 42010: 92011: 52012: 62013: 112014: 82015: 52016: 52017: 82018: 22019: 42020: 92021: 22022: 72023: 72024: 72025: 92026 (partial year): 6
2007high 11 (2007) · low 2 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KDI

199in 2025

2007: 91 days median2008: 148 days median2009: 236 days median2010: 186 days median2011: 85 days median2012: 153 days median2013: 247 days median2014: 164 days median2015: 69 days median2016: 230 days median2017: 188 days median2019: 263 days median2020: 266 days median2022: 259 days median2023: 157 days median2024: 235 days median2025: 199 days median2026 (partial year): 154 days median
2007high 266 (2020) · low 69 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KDI

2in 2025

2007: 42009: 32010: 12011: 42012: 12013: 22014: 32015: 52016: 42017: 12018: 12019: 62021: 22022: 172023: 8, 8 Class I2024: 4, 2 Class I2025: 22026 (partial year): 2
2007high 17 (2022) · low 0 (2008)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · KDI

2,786in 2025

2007: 9162008: 1,0422009: 5222010: 8232011: 2,2702012: 1,7652013: 2,3602014: 6,1542015: 4,1822016: 7662017: 9632018: 1,7162019: 1,5872020: 1,6332021: 1,9442022: 2,1802023: 2,6922024: 2,4412025: 2,786
2007high 6,154 (2014) · low 522 (2009)2025

MAUDE reports naming product code KDI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711914916
2008614801,042
200942363522
201091861823
201158542,270
2012615311,765
20131124722,360
2014816436,154
201556954,182
201652304766
201781881963
20182—11,716
2019426361,587
2020926601,633
20212—21,944
20227259172,180
202371578 (8)2,692
202472354 (2)2,441
2025919922,786
202661542—

What is it indicated for?

The DYNAMIC Hollow Fiber Dialyzer DS-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient’s illness.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Dynamic Technology Corp.

4 FDA decisions under this applicant name. See the company

  • K011537Dynamic Hollow Fiber Dialyzer DS-Series, Model: Polysulfone 100 HFS, Polysulfone 130 HFSDynamic Technology Corp. · 2002
  • K990159Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp. · 1999
  • K973291Dynamic Hollow Fiber Dialyzer DC-SeriesDynamic Technology Corp. · 1997

Recent decisions in KDI

The KDI category page

  • K261203multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLC · 2026
  • K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC · 2026
  • K260533Elisio™-HNipro Medical Corporation · 2026
  • K252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLC · 2026

https://510kreport.com/device/K982134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982134: Dynamic Hollow Fiber Dialyzer DS-Series Model as-851.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982134

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026