510(k) Report

510(k) · Cleared

Cleared

Cyber 120 Hemodialyzer

K801377510(k) TraditionalCleared Aug 27, 198077-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

Cyberex Corp. · FJG Dialyzer, Parallel Flow

Cleared on Aug 27, 1980 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 27, 1980
Review
77 days
Class
Class II
Product code
FJG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K801377Source: 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.

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

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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 FJG devices

FJG Dialyzer, Parallel Flow: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FJG

FDA has decided no FJG device since 2007.

Median 510(k) review, days · FJG

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

Recalls per year · FJG

No recall names FJG since 2007.

Adverse event reports per year · FJG

No MAUDE report names FJG 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 Cyberex Corp.

4 FDA decisions under this applicant name. See the company

  • K810837Cyber 80 HemodialyzerCyberex Corp. · 1981
  • K802478Cyber 120 HemodialyzerCyberex Corp. · 1981
  • K790824Repgreen Ultrafiltration MonitorCyberex Corp. · 1979

Recent decisions in FJG

The FJG category page

  • K933681Gambro Lundia Pro 100, 500, 600 DialyzersCobe Renal Care, Inc. · 1994
  • K933680Gambro Lundia Pro 200 DialyzerCobe Renal Care, Inc. · 1994
  • K920693Dextrolyte II Peritoneal Dialysis 48-3028-9National Medical Care, Medical Products Div., Inc. · 1992
  • K915504Gambro Lundia Alpha HemodialyzersC.G.H. Medical, Inc. · 1992
  • K901368Hemospal Kits A1, A2D, AO, & A1DGambro-Hospal, Inc. · 1990

https://510kreport.com/device/K801377 · printed Nov 4, 2026

Cite this page

510(k) Report. “K801377: Cyber 120 Hemodialyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801377

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