510(k) Report

510(k) · Cleared

Cleared

Tens Max

K823388510(k) TraditionalCleared Jan 8, 198354-day reviewClass II21 CFR 864.7340

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

Fujisawa Electronics Co. · GFK Fibrinogen Determination Standards And Controls

Cleared on Jan 8, 1983 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 8, 1983
Review
54 days
Class
Class II
Product code
GFK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K823388Source: 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 GFK devices

GFK Fibrinogen Determination Standards And Controls: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFK

FDA has decided no GFK device since 2007.

Median 510(k) review, days · GFK

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

Recalls per year · GFK

No recall names GFK since 2007.

Adverse event reports per year · GFK

No MAUDE report names GFK 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—

https://510kreport.com/device/K823388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K823388: Tens Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K823388

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