510(k) · Cleared
ClearedUnscented Interlabial Menstrual Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procter & Gamble Co. · HHD Pad, Menstrual, Unscented
Cleared on Jan 18, 2000 as substantially equivalent to K881384 (Xtramedics, Inc., 1989) and 1 other predicate after a 64-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jan 18, 2000
- Review
- 64 days
- Class
- Class I
- Product code
- HHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K844601 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK844601 Unscented Menstrual PadProcter & Gamble Mfg. Co. · 1985
- This deviceK993870 Unscented Interlabial Menstrual PadProcter & Gamble Co. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844601 | Unscented Menstrual Pad | Procter & Gamble Mfg. Co. | 1985 | — |
| 0 (this device) | K993870 | Unscented Interlabial Menstrual Pad | Procter & Gamble Co. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HHD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K881384 | Interlabial PadSummary page 1…4 (FAX) November 11, 1999 Unscented interlabial Menstrual Pad Interlabial Pad Unscented Menstrual Pad (per 21 CFR 884.5435) Fresh 'n Fit Padette®, Xtramedics, Inc., K881384 Always® Unscented Pantiliners, Procter & Gamble, K844601 Device Description: The device has 3 primary components: 1. The permea… | 1989 |
| * | K844601 | Unscented Menstrual PadSummary page 1…l Pad Interlabial Pad Unscented Menstrual Pad (per 21 CFR 884.5435) Fresh 'n Fit Padette®, Xtramedics, Inc., K881384 Always® Unscented Pantiliners, Procter & Gamble, K844601 Device Description: The device has 3 primary components: 1. The permeable topsheet allows fluid to pass through into the core. 2… | 1985 |
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 does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All HHD devicesHHD Pad, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHD
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · HHD
Too few HHD 510(k)s in any year since 2007 to give a median.
Recalls per year · HHD
No recall names HHD since 2007.
Adverse event reports per year · HHD
11in 2025
MAUDE reports naming product code HHD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Unscented Interiablal Menstrual Pad can be wom any time of the day or night in the following ways:
Alone far light and medium (menstrual) flow
In combination with tampons or Pads for extra protection during heavy (menstrual) flow
Alone for vaginal discharge or slight urine loss associated with laughs, coughs, and sneezes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993870 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993870: Unscented Interlabial Menstrual Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993870
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026