510(k) · Cleared
ClearedKurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heinz Kurz GmbH Medizintechnik · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Jan 30, 2004 as substantially equivalent to K974653 (Specialty Surgical Products, Inc., 1998) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jan 30, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K974653 (1998). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K260266Tympendi™ (810)Grace Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974653 | Silicone Elastomer Sheeting | Specialty Surgical Products, Inc. | 1998 | — |
| 0 (this device) | K033796 | Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS | Heinz Kurz GmbH Medizintechnik | 2004 | — |
| +1 | K260266 | Tympendi™ (810) | Grace Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KHJ? 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 KHJ device
- #1 K260266 Tympendi™ (810)score 12.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K974653 | Silicone Elastomer SheetingSummary page 1…Equivalence: function, performance and material to Silicone Elastomer Sheeting marketed by Specialty Surgical Products, Inc., K974653. Device Description: General KURZ Silicone Strips are manufactured from a medical grade… | 1998 |
| * | K022223 | Aart Silicone SheetingSummary page 3…RECONSTRUCTIVE PRODUCTS TECHNOLOGIES K974653 K022223 Material Silicone sheeting Silicone Silicone sheeting YES… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260266 | Tympendi™ (810) | 2026 | 0 |
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.
- Of its descendants, K260266 (Grace Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KHJ devicesKHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KHJ
46in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHJ
1in 2025
MAUDE reports naming product code KHJ, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 46 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
KURZ Silicone Strips are designed to temporarily cover the tympanic membrane after surgical procedures in the middle ear.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033796 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033796: Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033796
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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