510(k) Report

510(k) · Cleared

Cleared

Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111

K990159510(k) TraditionalCleared Apr 19, 199990-day reviewClass II21 CFR 876.5820

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

Dynamic Technology Corp. · FJI Dialyzer, Capillary, Hollow Fiber

Cleared on Apr 19, 1999 as substantially equivalent to K914790 (National Medical Care, Medical Products Div., Inc., 1993) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1987.

Decided
Apr 19, 1999
Review
90 days
Class
Class II
Product code
FJI
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K864831 (1987). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor1990: 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: 2 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 deviceK990159 Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic 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)K990159Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199310
FIG. 1 — Lineage of K990159, 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 FJI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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
*K914790Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-R
Summary page 1
…and a wall thickness of 8 microns. The fibers used in this device which is substantially equivalent to the fibers utilized in the Focus R-Series Hollow Fiber Dialyzers (K914790) and Gambro GFS plus Series Hemodialyzer (K902481), which have been previously approved under a 510(k) Notification. The wall thi…
National Medical Care, Medical Products Div., Inc.1993—
*K902481Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber
Summary page 1
…d in this device which is substantially equivalent to the fibers utilized in the Focus R-Series Hollow Fiber Dialyzers (K914790) and Gambro GFS plus Series Hemodialyzer (K902481), which have been previously approved under a 510(k) Notification. The wall thickness of the hollow fibers in Focus R-Series Holl…
Gambro, Inc.1990—
*K973291Dynamic Hollow Fiber Dialyzer DC-Series
Summary page 2
…valent in function, design, and operation to the Focus R-Series Hollow Fiber Dialyzers , Gambro GFS plus Series Hemodialyzer, and DYNAMIC Hollow Fiber Dialyzer DC-Series(K973291), which have been previously approved for marketing in the United States under 510(K) Notifications. Intended Use The DYNAMIC H…
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 4 ancestors has a recall.

How does its category compare?

All FJI devices

FJI Dialyzer, Capillary, Hollow Fiber: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FJI

1in 2019

2013: 12019: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJI

Too few FJI 510(k)s in any year since 2007 to give a median.

Recalls per year · FJI

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FJI

145in 2025

2007: 172008: 112009: 32010: 322011: 472012: 2112013: 5532014: 6332015: 5612016: 5622017: 1822018: 112019: 202020: 162021: 122022: 22023: 512024: 1522025: 145
2007high 633 (2014) · low 2 (2022)2025

MAUDE reports naming product code FJI, 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
20070—017
20080—011
20090—03
20100—032
20110—047
20120—0211
20131—0553
20140—0633
20150—0561
20160—0562
20170—0182
20180—011
20191—020
20200—016
20210—012
20220—02
20230—051
20240—0152
20250—1145
20260—0—

What is it indicated for?

The DYNAMIC Hollow Fiber Dialyzer DH-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
  • K982134Dynamic Hollow Fiber Dialyzer DS-Series Model as-851Dynamic Technology Corp. · 1999
  • K973291Dynamic Hollow Fiber Dialyzer DC-SeriesDynamic Technology Corp. · 1997

Recent decisions in FJI

The FJI category page

  • K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC · 2019
  • K122952Nipro Pureflux-L HemodialyzerNipro Medical Corporation · 2013
  • K043342Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H…Gambro Renal Products · 2005
  • K010366Disposable Storage CapMolded Products, Inc. · 2001
  • K011148Ultraconcentrator SystemInterpore Cross Intl. · 2001

https://510kreport.com/device/K990159 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990159: Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990159

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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