510(k) Report

510(k) · Cleared

Cleared

Cautery Tip Cleaning Pad

K853315510(k) TraditionalCleared Aug 21, 198514-day review

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

Kleen Test Products

Cleared on Aug 21, 1985 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 21, 1985
Review
14 days
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K853315Source: FDA 510(k) database · How lineage is built

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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.

Cite this page

510(k) Report. “K853315: Cautery Tip Cleaning Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853315

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