510(k) · Cleared
ClearedClip Partial Prosthesis-Titanium Dresden, Model 1002 250-257
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heinz Kurz GmbH Medizintechnik · ETB Prosthesis, Partial Ossicular Replacement
Cleared on Nov 9, 2001 as substantially equivalent to K972492 (Heinz Kurz, 1997) after an 11-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Nov 9, 2001
- Review
- 11 days
- Class
- Class II
- Product code
- ETB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972492 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972492 Bell Prosthesis (Partial)Heinz Kurz · 1997
- This deviceK013573 Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257Heinz Kurz GmbH Medizintechnik · 2001
- Descendant · cites it directly · 1 of its ownK241261 mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT…MED-EL Elektromedizinische Geräte GmbH · 2025
- Descendant · 2 generations on · 0 of its ownK260718 mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis…MED-EL Elektromedizinische Geräte GmbH · 2026
Most influential descendants
Showing 2 of 2 · See all- K241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and…MED-EL Elektromedizinische Geräte GmbH · 2025 · cites it directly1descendant
- K260718mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm)…MED-EL Elektromedizinische Geräte GmbH · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972492 | Bell Prosthesis (Partial) | Heinz Kurz | 1997 | — |
| 0 (this device) | K013573 | Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257 | Heinz Kurz GmbH Medizintechnik | 2001 | — |
| +1 | K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial… | MED-EL Elektromedizinische Geräte GmbH | 2025 | — |
| +2 | K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm)… | MED-EL Elektromedizinische Geräte GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 ETB? 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 ETB device
- #1 K241142 mAXIS Stapes Prosthesis, mLOOP Stapes…score 13.2 · 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 |
|---|---|---|---|
| * | K972492 | Bell Prosthesis (Partial)Summary page 2…Amtsgericht Tiibingen IBAN DE38 6406 1854 0070 150001 IRAN DF1RA417 0N 1901 4032 nn U=z N <. 2.6 Modification to Existing Device: [807.92 (a)(3)] N——” K 972492 Bell Prosthesis (Partial) | Heinz Kurz GmbH - Medizintechnik - Postfach 39 - D-72142 Dussfnigared 08/04/97 Heinz Kurz GmbH Medi… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and… | 2025 | 1 |
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?
How does its category compare?
All ETB devicesETB Prosthesis, Partial Ossicular Replacement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ETB
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ETB
Too few ETB 510(k)s in any year since 2007 to give a median.
Recalls per year · ETB
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ETB
5in 2025
MAUDE reports naming product code ETB, 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 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 2 | — | 0 | 5 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Ossicle replacement in case of interrupted sound conducting chain in patients with intact, mobile stapes.
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/K013573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013573: Clip Partial Prosthesis-Titanium Dresden, Model 1002 250-257.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013573
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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