510(k) · Cleared
ClearedBONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-El Elektromedizinische Geraete GmbH · PFO Active Implantable Bone Conduction Hearing System
Cleared on Jul 29, 2020 as substantially equivalent to K183373 (Med-El Elektromedizinische Geraete GmbH, 2019) after a 149-day review. Its family tree reaches back 2 generations to 2018.
- Decided
- Jul 29, 2020
- Review
- 149 days
- Class
- Class II
- Product code
- PFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170009 (2018). No later device cites it as a predicate yet.
- Root · 2 generations backDEN170009 BonebridgeMed-El Elektromedizinische Geraete GmbH · 2018
- 1 generation backK183373 BonebridgeMed-El Elektromedizinische Geraete GmbH · 2019
- This deviceK200504 BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 RemoteMed-El Elektromedizinische Geraete GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170009 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2018 | — |
| −1 | K183373 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2019 | — |
| 0 (this device) | K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | Med-El Elektromedizinische Geraete GmbH | 2020 | — |
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 PFO? 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 PFO device
- #1 K260902 Cochlear™ Osia® 3(I) Sound Processor;Cochlear™…score 13.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K183373 | BonebridgeSummary page 6…1 2. Predicate Devices Samba BB, SYMFIT 7.0 and Remote Control - MED-EL Elektromedizinische Geraete GmbH (K183373) 3. Device Description The MED-EL BONEBRIDGE System augments hearing by providing acoustic input to the inner ear via bone con… | 2019 |
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?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All PFO devicesPFO Active Implantable Bone Conduction Hearing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PFO
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PFO
114in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PFO
No recall names PFO since 2007.
Adverse event reports per year · PFO
994in 2025
MAUDE reports naming product code PFO, 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 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 4 | 114 | 0 | 25 |
| 2020 | 2 | — | 0 | 70 |
| 2021 | 0 | — | 0 | 237 |
| 2022 | 1 | — | 0 | 306 |
| 2023 | 1 | — | 0 | 473 |
| 2024 | 2 | — | 0 | 712 |
| 2025 | 0 | — | 0 | 994 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
INTENDED USE: The Bonebridge is intended to improve hearing for patients with conductive or mixed hearing losses, bilateral fitting. and single-sided deafuess. INDICATIONS: The Bonebridge bone conduction hearing implant system is intended for the following patients and indications: - Patients 12 years of age or older. - Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone…
Read the full statement (328 words)
INTENDED USE:
The Bonebridge is intended to improve hearing for patients with conductive or mixed hearing losses, bilateral fitting. and single-sided deafuess.
INDICATIONS:
The Bonebridge bone conduction hearing implant system is intended for the following patients and indications:
- Patients 12 years of age or older.
- Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, I, 2 and 3kHz) should be better than or equal to 45 dB HL.
- Bilateral fitting of the Bonebridge is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than JO dB on average measured at 0.5, I, 2 and 3kHz, or less than 15 dB at individual frequencies.
- Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafuess or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, I, 2 and 3kHz).
- The Bonebridge for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
- Prior to receiving the device, it is recommended that an individual has experience with appropriately fit air conduction or bone conduction hearing aids.
CONTRAINDICATIONS:
- Chronic or non-revisable vestibular or balance disorders.
- Abnormally progressive hearing loss.
- Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.
- Skin or scalp conditions that may preclude attachment of the audio processor or that may interfere with the use of the audio processor.
- Skull size or abnormality that would preclude appropriate placement of the Bonebridge implant as determined by CT scan.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200504: BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200504
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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