510(k) · Cleared
ClearedMinimuffs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natus Medical, Inc. · EWE Protector, Hearing (Circumaural)
Cleared on Feb 9, 1995 as substantially equivalent to K781907 (Crown Delta Corp., 1978) after a 468-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Feb 9, 1995
- Review
- 468 days
- Class
- Class U
- Product code
- EWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K781907 (1978). No later device cites it as a predicate yet.
- Root · 1 generation backK781907 Ear Stopples for Noise AttentionCrown Delta Corp. · 1978
- This deviceK935160 MinimuffsNatus Medical, Inc. · 1995
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781907 | Ear Stopples for Noise Attention | Crown Delta Corp. | 1978 | — |
| 0 (this device) | K935160 | Minimuffs | Natus Medical, Inc. | 1995 | — |
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 EWE? 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? (1)
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 |
|---|---|---|---|
| * | K781907 | Ear Stopples for Noise AttentionSummary page 1…Attenuators Product Classification: Class 11 Classification Name: Protector, Hearing (Circumaural):EN 77 EWE 3. Predicate Device: Crown Delta Corp. Ear Stopples, 5 10(k):K781907 4. Description of Device: Natus Medical Inc MiniMuffsgy, are thermoformed long chain polyethylene domed circumaural noise atten… | 1978 |
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?
- Its one ancestor has no recall.
How does its category compare?
All EWE devicesEWE Protector, Hearing (Circumaural): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWE
FDA has decided no EWE device since 2007.
Median 510(k) review, days · EWE
Too few EWE 510(k)s in any year since 2007 to give a median.
Recalls per year · EWE
No recall names EWE since 2007.
Adverse event reports per year · EWE
2in 2019
MAUDE reports naming product code EWE, 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 | 1 |
| 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 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 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?
The Natus Medical Inc. MiniMuffsTM Neonatal Noise Attenuators are intended for use on newborns to provide reduction in the sound level reaching the newborn’s ear. Reducing noise can stabilize the heart rate, decrease adverse physiological states such as oxygen desaturation, can decrease behavior states such as crying and fussing, and can lead to an increase in length of sleep.
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/K935160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935160: Minimuffs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935160
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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