510(k) · Cleared
ClearedDurasil I and Durasil II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hanson Medical, Inc. · MIB Elastomer, Silicone Block
Cleared on Dec 24, 1997 as substantially equivalent to K971480 (Allied Biomedical Corp., 1997) after an 85-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 24, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971480 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971480 Duralastic I and Duralastic IIAllied Biomedical Corp. · 1997
- This deviceK973730 Durasil I and Durasil IIHanson Medical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971480 | Duralastic I and Duralastic II | Allied Biomedical Corp. | 1997 | — |
| 0 (this device) | K973730 | Durasil I and Durasil II | Hanson Medical, Inc. | 1997 | — |
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 MIB? 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 MIB device
- #1 K241150 MISTI Silicone Implantscore 8.0 · 2 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 |
|---|---|---|---|
| * | K971480 | Duralastic I and Duralastic IISummary page 1…ound in Applied Master File - MAF 607. SUBSTANTIAL EQUIVALENCE These products are substantially equivalent to Duralastic I and II made by Allied Biomedical's Sheeting (K971480). Because Durasil Sheeting is made from the same materials using the same processes and made in the same sizes and thicknesses fo… | 1997 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MIB devicesMIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MIB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MIB
102in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MIB
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIB
18in 2025
MAUDE reports naming product code MIB, 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 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 3 | 102 | 0 | 19 |
| 2023 | 1 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 0 | — | 3 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Durasil I (Short Term) nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joint spacers, and other short term uses according to the surgeon's determination. Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, dural…
Read the full statement (115 words)
Durasil I (Short Term) nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joint spacers, and other short term uses according to the surgeon's determination.
Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, dural covering .00S inch, nasal septal repair, tendon anastomosis,
neural repair - .007 inch. correction of strabismus .010 inch,
galea vrepair - .020 inch, orbital floor repair .040inch,
hemodialysis shunt anchors .060. Reinforced - Facilitation of
osteogenesis .007inch, repair of urethral strictures .007inch,
staged repair of omphaloccel .020inch, repair of orbital floor
fractures .040inch.
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/K973730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973730: Durasil I and Durasil II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973730
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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