510(k) Report

510(k) · Cleared

Cleared

Clirans Taf Hollow Fiber Dialyzer

K854280510(k) TraditionalCleared Dec 13, 198551-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

Terumo Medical Corp. · FJI Dialyzer, Capillary, Hollow Fiber

Cleared on Dec 13, 1985 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Dec 13, 1985
Review
51 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 1997: 1 descendant cleared1990200020102020
  1. This deviceK854280 Clirans Taf Hollow Fiber DialyzerTerumo Medical Corp. · 1985
  2. Descendant · cites it directly · 0 of its ownK970708 Clirans T-Series Hollow Fiber DialyzersTerumo Medical Corp. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K970708Clirans T-Series Hollow Fiber DialyzersTerumo Medical Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K854280Clirans Taf Hollow Fiber DialyzerTerumo Medical Corp.1985—
+1K970708Clirans T-Series Hollow Fiber DialyzersTerumo Medical Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K854280, 1985–1997Source: 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 has not posted a summary or statement for it, 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
K970708Clirans T-Series Hollow Fiber DialyzersTerumo Medical Corp.19970

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, K970708 (Terumo Medical Corp., 1997) 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—

More from Terumo Medical Corp.

143 FDA decisions under this applicant name. See the company

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  • K102008GlidesheathTerumo Medical Corp. · 20101 recall
  • K091329Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 20091 recall

Recent decisions in FJI

The FJI category page

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https://510kreport.com/device/K854280 · printed Nov 5, 2026

Cite this page

510(k) Report. “K854280: Clirans Taf Hollow Fiber Dialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K854280

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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