510(k) · Cleared
ClearedFaceplate Assembly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Finetone Hearing Instruments · LRB Face Plate Hearing Aid
Cleared on Feb 20, 1998 after a 102-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 20, 1998
- Review
- 102 days
- Class
- Class I
- Product code
- LRB
- 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 LRB? 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 LRB devicesLRB Face Plate Hearing Aid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRB
FDA has decided no LRB device since 2007.
Median 510(k) review, days · LRB
Too few LRB 510(k)s in any year since 2007 to give a median.
Recalls per year · LRB
No recall names LRB since 2007.
Adverse event reports per year · LRB
No MAUDE report names LRB 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 | 0 | — | 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 M-LIN is a Class A linear circuit. Available options are the Low cut, High cut and Output controls. The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies). The M-PP is a Class B circuit. Available options are the Low cut, High cut and ouput controls. The indication for use of the air…
Read the full statement (456 words)
The M-LIN is a Class A linear circuit. Available options are the Low cut, High cut and Output controls.
The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies).
The M-PP is a Class B circuit. Available options are the Low cut, High cut and ouput controls.
The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies).
The M-HLIN is a Class A linear circuit utilizing a hybrid amplifier. Available options are the Low cut, High cut and Output controls.
The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies).
The M-D is a Class D linear circuit. Available options are the Low cut, High cut and Output controls.
The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies).
The M-D/ASP is a Automatic Signal Processing circuit utilizing Class D technology. Available options are the Asp, Low cut and High cut controls.
The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies).
The M-D/AGCI is an input compression circuit utilizing Class D technology. Available iptions are the Low cut and High cut controls.
The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies).
The M-KAMP detects and amplifies quiet sounds. In foud situations it provides low distortion and high fedelity sound. Available options are the Threshold Kneepoint and low cut controls.
The indication for use of the air conductin hearing aids in this submissin is to amplify sound for individuals with imparied hearing. The devices are indicated for individuals with losses in the following category(ies).
The M-EQII is a Wide Dynamic Range, duel channel, input compression circuit which utilizes Class D technology. Available options are the Threshold Kneepoint, Low Frequency Gain, High Frequency Gain, Crossover and Output controls.
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974219: Faceplate Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974219
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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