510(k) · Cleared
ClearedEar Muffins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Logic Systems Corp. · HCC Device, Biofeedback
Cleared on Oct 15, 2001 as substantially equivalent to K936039 (Natus Medical, Inc., 1995) after an 80-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Oct 15, 2001
- Review
- 80 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K936039 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK936039 Algo-2 Newborn Hearing ScreenerNatus Medical, Inc. · 1995 · Recalled
- This deviceK012384 Ear MuffinsBio-Logic Systems Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K936039 | Algo-2 Newborn Hearing Screener | Natus Medical, Inc. | 1995 | 1 |
| 0 (this device) | K012384 | Ear Muffins | Bio-Logic Systems Corp. | 2001 | — |
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 HCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K936039 | Algo-2 Newborn Hearing ScreenerSummary page 1…r 21 CFR section 882. 1900). PREDICATE DEVICE: Natus Medical Inc. Ear Coupler Earphones, part of ALGO Disposable Kit used with ALGO-2 Newborn Hearing Screener, 510(k) #K936039. Page 10 DESCRIPTION OF THE DEVICE: The Bio-logic Ear Muffins consist of a pair of single-use, disposable foam… | 1995 |
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 a recall.
- 2 other devices also cite its predicate K936039.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, 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 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bio-logic Ear Muffins® is a disposable earphone device intended to be used as an accessory to the Bio-logic ABaer / Navigator Pro auditory evoked response screening and diagnostic systems, and the Natus Medical Inc. ALGO series auditory evoked response screening systems. The Ear Muffins® device performs as the means for delivering the auditory stimulus from the auditory stimulator to the ear of the patient under test.
The Bio-logic Ear Muffins® device is especially indicated for use in the auditory evoked response screening of newborn infants, because the Ear Muffins® can be placed to cover the entire ear of the infant, so nothing has to be placed into the ear canal.
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/K012384 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012384: Ear Muffins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012384
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026