510(k) Report

510(k) · Decided

Decided

Seizure Emergency Equipment Kit; Seizure Kit

K973176510(k) TraditionalDecided Nov 21, 199788-day review

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

Lotus Technologies · KGA (no longer in FDA’s product-code list)

Cleared on Nov 21, 1997 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Nov 21, 1997
Review
88 days
Product code
KGA
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K973176Source: FDA 510(k) database · How lineage is built

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Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.

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.

What is it indicated for?

During a seizure emergency, this device is indicated for use by a caretaker to render first aid to a person who is having a seizure.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973176 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973176: Seizure Emergency Equipment Kit; Seizure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973176

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026