510(k) · Cleared
ClearedBCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
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 Oct 9, 2020 as substantially equivalent to K191457 (Med-El Elektromedizinische Geraete GmbH, 2019) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Oct 9, 2020
- Review
- 84 days
- Class
- Class II
- Product code
- PFO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN170009 (2018). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backDEN170009 BonebridgeMed-El Elektromedizinische Geraete GmbH · 2018
- This deviceK201983 BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI…Med-El Elektromedizinische Geraete GmbH · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170009 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2018 | — |
| 0 (this device) | K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4… | Med-El Elektromedizinische Geraete GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit…Summary page 4…t Product Code: PFO IV. Predicate Devices Trade Name: BONEBRIDGE BCI Lifts K191457 BCI 602 Lifts (1 mm) DEN170009 Traditional 510 (k) submission –… | 2019 |
| * | DEN170009 | BonebridgeSummary page 4…Trade Name: BONEBRIDGE BCI Lifts K191457 BCI 602 Lifts (1 mm) DEN170009 Traditional 510 (k) submission – 510(k) Summary BCI Lifts (1 mm)… | 2018 |
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?
- 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?
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, 1, 2 and 3 kHz) should be better than or equal to 45 dB HL. Bilateral fitting of the BONEBRIDGE is intended for patients having a…
Read the full statement (228 words)
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, 1, 2 and 3 kHz) 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 10 dB on average measured at 0.5, 1, 2 and 3 kHz, 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 deafness 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, 1, 2 and 3 kHz).
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.
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/K201983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201983: BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201983
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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