510(k) Report

510(k) · Cleared

Cleared

Hollow Fiber Dialyzer Holder

K802075510(k) TraditionalCleared Sep 16, 198020-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

Renal Devices, Inc. · FKI Set, Dialyzer Holder

Cleared on Sep 16, 1980 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 16, 1980
Review
20 days
Class
Class II
Product code
FKI
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K802075Source: FDA 510(k) database · 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.

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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?

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.

How does its category compare?

All FKI devices

FKI Set, Dialyzer Holder: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKI

FDA has decided no FKI device since 2007.

Median 510(k) review, days · FKI

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

Recalls per year · FKI

No recall names FKI since 2007.

Adverse event reports per year · FKI

No MAUDE report names FKI since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Renal Devices, Inc.

4 FDA decisions under this applicant name. See the company

  • K810612HemophronRenal Devices, Inc. · 1981
  • K801559Hollo Fiber DialyzerRenal Devices, Inc. · 1980
  • K790696Rdi-1 Hollow Fiber DialyzerRenal Devices, Inc. · 1979

Recent decisions in FKI

The FKI category page

  • K843504Amer. Bentley Hemofilter Holder HFH-1American Bentley · 1984
  • K811292Parallel Plate Dialyzer HolderExtracorporeal Medical Specialities, Inc. · 1981

https://510kreport.com/device/K802075 · printed Nov 4, 2026

Cite this page

510(k) Report. “K802075: Hollow Fiber Dialyzer Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K802075

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