510(k) · Cleared
ClearedSolid Dilicone Implants, Sdilicone Sponge Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mira, Inc. · HQX Implant, Orbital, Extra-Ocular
Cleared on Jun 5, 1996 as substantially equivalent to K780987 (Medical Instrument Research Assoc., Inc., 1978) after a 469-day review. Its family tree reaches back 1 generation to 1978. 2 later devices descend from it.
- Decided
- Jun 5, 1996
- Review
- 469 days
- Class
- Class II
- Product code
- HQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K780987 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK780987 Soft Silicone Elastomer Sponge ExplantMedical Instrument Research Assoc., Inc. · 1978
- This deviceK950806 Solid Dilicone Implants, Sdilicone Sponge ImplantsMira, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK083342 Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK023481 Microvision Scleral Buckling ComponentsMicrovision, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780987 | Soft Silicone Elastomer Sponge Explant | Medical Instrument Research Assoc., Inc. | 1978 | — |
| 0 (this device) | K950806 | Solid Dilicone Implants, Sdilicone Sponge Implants | Mira, Inc. | 1996 | — |
| +1 | K083342 | Orbital Reconstructive Implant II | Evera Medical, Inc. | 2009 | — |
| +1 | K023481 | Microvision Scleral Buckling Components | Microvision, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 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 HQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K780987 | Soft Silicone Elastomer Sponge ExplantSummary page 1…Inc. claims substantial equivalence of the Solid Silicone and Silicone Sponge Implants to currently marketed Solid Silicone (preamendment) and Silicone Sponge Implants (K780987A) manufactured and marketed by MIRA, Inc. DEVICE DESCRIPTION Solid Silicone and Silicone Sponge Implants are molded extruded si… | 1978 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K083342 (Evera Medical, Inc., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HQX devicesHQX Implant, Orbital, Extra-Ocular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQX
FDA has decided no HQX device since 2007.
Median 510(k) review, days · HQX
Too few HQX 510(k)s in any year since 2007 to give a median.
Recalls per year · HQX
No recall names HQX since 2007.
Adverse event reports per year · HQX
2in 2022
MAUDE reports naming product code HQX, 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 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
These devices are used to "buckle” the sclera in retinal reattachment surgery.
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/K950806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950806: Solid Dilicone Implants, Sdilicone Sponge Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950806
Report an extraction error
Are you the manufacturer?
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