510(k) · Cleared
ClearedDuralastic I and Duralastic II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allied Biomedical Corp. · MIB Elastomer, Silicone Block
Cleared on May 28, 1997 after a 35-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 28, 1997
- Review
- 35 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK971480 Duralastic I and Duralastic IIAllied Biomedical Corp. · 1997
- Descendant · cites it directly · 0 of its ownK973730 Durasil I and Durasil IIHanson Medical, Inc. · 1997
Most influential descendants
Showing 1 of 1 · See all- K973730Durasil I and Durasil IIHanson Medical, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971480 | Duralastic I and Duralastic II | Allied Biomedical Corp. | 1997 | — |
| +1 | K973730 | Durasil I and Durasil II | Hanson Medical, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 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? (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 |
|---|---|---|---|
| * | — | Applied Biomaterial Technologies Duralastic Sheeting Named without a submission number | |
| * | — | Dow Corning Silastic Sheeting Named without a submission number |
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 |
|---|---|---|---|
| K973730 | Durasil I and Durasil II | 1997 | 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?
- Of its descendants, K973730 (Hanson Medical, Inc., 1997) has gone furthest, with 0 descendants of its own.
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?
Duralastic 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. Duralastic I (Long Term) Nonreinforced - Tympanic Membrane Repair…
Read the full statement (110 words)
Duralastic 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.
Duralastic I (Long Term) Nonreinforced - Tympanic Membrane Repair, Dural Covering .005inch, Nasal Septal Repair, Tendon Anastomosis, neural repair - .007inch. Correction of Strabismus .010inch, Galea Repair-.020inch, Orbital Floor Repair .040inch., Hemodialysis Shunt Anchors .060inch. Reinforced - Facilitation of Osteogenesis .007inch, repair of urethral strictures .007inch, Staged Repair of omphalocoel .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/K971480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971480: Duralastic I and Duralastic II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971480
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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