510(k) Report

510(k) · Cleared

Cleared

Lunapads

K010986510(k) TraditionalCleared Jun 13, 200172-day reviewClass I21 CFR 884.5435

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

Lunapads International Products, Ltd. · NUQ Pad, Menstrual, Reusable

Cleared on Jun 13, 2001 after a 72-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 13, 2001
Review
72 days
Class
Class I
Product code
NUQ
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K010986Source: 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 lists a 510(k) statement for it but has not posted the file, 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 NUQ devices

NUQ Pad, Menstrual, Reusable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NUQ

FDA has decided no NUQ device since 2007.

Median 510(k) review, days · NUQ

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

Recalls per year · NUQ

No recall names NUQ since 2007.

Adverse event reports per year · NUQ

7in 2023

2023: 7
2007high 7 (2023) · low 0 (2007)2025

MAUDE reports naming product code NUQ, not matched to any one device; reports are not rates.

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—07
20240—00
20250—00
20260—0—

https://510kreport.com/device/K010986 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010986: Lunapads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010986

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