510(k) Report

510(k) · Cleared

Cleared

Somas Human Spinal Fluid Control

K840974510(k) TraditionalCleared Apr 5, 198430-day reviewClass I21 CFR 866.5860

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

Somas Medical Industries, Inc. · DFI Total Spinal-Fluid, Antigen, Antiserum, Control

Cleared on Apr 5, 1984 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 5, 1984
Review
30 days
Class
Class I
Product code
DFI
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K840974Source: 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 DFI devices

DFI Total Spinal-Fluid, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DFI

FDA has decided no DFI device since 2007.

Median 510(k) review, days · DFI

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

Recalls per year · DFI

No recall names DFI since 2007.

Adverse event reports per year · DFI

No MAUDE report names DFI 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 Somas Medical Industries, Inc.

6 FDA decisions under this applicant name. See the company

  • K862179Somas Liquid Urine ControlSomas Medical Industries, Inc. · 1986
  • K842134Somas Coomasie Blue Total Protein AssaySomas Medical Industries, Inc. · 1984
  • K840486Total Bilirubin ReagentSomas Medical Industries, Inc. · 1984
  • K840485Total Iron Uibc/Tibc AssaySomas Medical Industries, Inc. · 1984
  • K833787Somas Chloride Assay KitSomas Medical Industries, Inc. · 1984

Recent decisions in DFI

The DFI category page

  • K854190Cantrol Spinal Fluid ControlCanyon Diagnostics, Inc. · 1985
  • K843122Resolve-CSFIsolab, Inc. · 19841 recall
  • K832821Fiax Igg TestIntl. Diagnostic Technology · 1983

https://510kreport.com/device/K840974 · printed Nov 6, 2026

Cite this page

510(k) Report. “K840974: Somas Human Spinal Fluid Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K840974

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