510(k) Report

510(k) · Cleared

Cleared

Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-R

K914790510(k) TraditionalCleared Mar 5, 1993499-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

National Medical Care, Medical Products Div., Inc. · FJI Dialyzer, Capillary, Hollow Fiber

Cleared on Mar 5, 1993 after a 499-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Mar 5, 1993
Review
499 days
Class
Class II
Product code
FJI
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1990200020102020
  1. This deviceK914790 Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-RNational Medical Care, Medical Products Div., Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK990159 Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K990159Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914790Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-RNational Medical Care, Medical Products Div., Inc.1993—
+1K990159Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K914790, 1993–1999Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990159Dynamic Hollow Fiber Dialyzer DH-Series, Model AH 90111Dynamic Technology Corp.19990

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?

  • Of its descendants, K990159 (Dynamic Technology Corp., 1999) has gone furthest, with 0 descendants of its own.

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—

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  • K930843Rapid Disconnect Y-Set, Cat. NO. 48-7000National Medical Care, Medical Products Div., Inc. · 1994
  • K920029Dextrolyte II Capd Trnsfer SetNational Medical Care, Medical Products Div., Inc. · 1992

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The FJI category page

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https://510kreport.com/device/K914790 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914790: Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914790

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026