510(k) · Cleared
ClearedFerris Polymem Sterile Breast Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ferris Mfg. Corp. · NTX Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
Cleared on Feb 22, 2005 after a 636-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 22, 2005
- Review
- 636 days
- Class
- Class I
- Product code
- NTX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
Planning a device in NTX? 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?
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.
How does its category compare?
All NTX devicesNTX Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NTX
FDA has decided no NTX device since 2007.
Median 510(k) review, days · NTX
Too few NTX 510(k)s in any year since 2007 to give a median.
Recalls per year · NTX
No recall names NTX since 2007.
Adverse event reports per year · NTX
1in 2017
MAUDE reports naming product code NTX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Over the Counter Use: To be worn inside the bra to:
Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding
Absorb milk leakage
Protect the nipple from abrasion and friction damage caused by bra or clothing
Help alleviate discomfort
Protect clothing from milk leakage
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031660: Ferris Polymem Sterile Breast Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031660
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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