510(k) · Cleared
ClearedInfrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver, Infrared Headset Receiver-Stereo, IT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phonic Ear, Inc. · EPF Hearing Aid, Group And Auditory Trainer
Cleared on Feb 25, 1998 after a 72-day review. The FDA summary names no predicate by number.
- Decided
- Feb 25, 1998
- Review
- 72 days
- Class
- Class II
- Product code
- EPF
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 EPF? 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?
The FDA summary names no predicate by number.
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 EPF devicesEPF Hearing Aid, Group And Auditory Trainer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EPF
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · EPF
Too few EPF 510(k)s in any year since 2007 to give a median.
Recalls per year · EPF
No recall names EPF since 2007.
Adverse event reports per year · EPF
No MAUDE report names EPF since 2007.
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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 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?
The Model PE 600 Series devices form the Impaired Group Amplification System which is used by adults and children in public halls, theaters, churches, courtrooms and other public gatherings and provide auditory assistance to hearing impaired persons. The Model PE 600E is a power amplifier which is combined with an infrared LED array. Audio signals from a sound system are processed and broadcast into the listening area by means of infrared light. The PE…
Read the full statement (239 words)
The Model PE 600 Series devices form the Impaired Group Amplification System which is used by adults and children in public halls, theaters, churches, courtrooms and other public gatherings and provide auditory assistance to hearing impaired persons.
The Model PE 600E is a power amplifier which is combined with an infrared LED array. Audio signals from a sound system are processed and broadcast into the listening area by means of infrared light.
The PE B800R is a body worn infrared receiver. It receives the infrared light signals from the PE 600E and converts these signals to high level audio signals required by the hearing impaired listener. The audio signals can be adjusted to meet the needs of the user.
The PE 601R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. This devise is capable of stereo reception so that different audio signals can be received simultaneously and fed to each ear separately.
The PE 602R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. The device is capable of receiving infrared light signals transmitted on two separate frequencies. A switch on the headset allows the user to select the program frequency desired. The selected program is heard in each ear.
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/K974658 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974658: Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver, Infrared Headset Receiver-Stereo, IT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974658
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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