510(k) · Cleared
ClearedMenicon Z Rigid Gas Permeable Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Menicon Co, Ltd. · HQD Lens, Contact (Other Material) - Daily
Cleared on Sep 23, 2008 as substantially equivalent to K013646 (Rose K International, Ltd., 2002) and 4 other predicates after a 124-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Sep 23, 2008
- Review
- 124 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K943177 (1994). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 4 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 3 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 2 generations backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- 1 generation backK071043 Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES…Bausch & Lomb, Inc. · 2007 · Recalled
- This deviceK081443 Menicon Z Rigid Gas Permeable Contact LensMenicon Co, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK103561 Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact LensMenicon Co, Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103561Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact LensMenicon Co, Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −4 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −3 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −2 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| −1 | K071043 | Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a)… | Bausch & Lomb, Inc. | 2007 | 2 |
| 0 (this device) | K081443 | Menicon Z Rigid Gas Permeable Contact Lens | Menicon Co, Ltd. | 2008 | — |
| +1 | K103561 | Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens | Menicon Co, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 HQD? 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 HQD device
- #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K013646 | Rose K Post Graft LensSummary page 1…icon claims substantial equivalence of the Menicon Z (tisilfocon A) to the following predicate devices. * Rose KPost Graft Rigid Gas Permeable Contact Lenses: K013646 • Dyna Intra-Limbal lens (enflufocon A &hexafocon A): K020006 * Boston XO (hexafocon A), Boston EQ (enflufocon B)… | 2002 |
| * | K020006 | Dyna Intra-Limbal LensSummary page 1…the following predicate devices. * Rose KPost Graft Rigid Gas Permeable Contact Lenses: K013646 • Dyna Intra-Limbal lens (enflufocon A &hexafocon A): K020006 * Boston XO (hexafocon A), Boston EQ (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Le… | 2002 |
| * | K013762 | Rigid Gas Permeable Contact LensSummary page 1…nflufocon A &hexafocon A): K020006 * Boston XO (hexafocon A), Boston EQ (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses: K013762, K0531 24, K071043. 4. Description of device The Menicon Z lens material, tisilfocon A is a thermoset copolymer derived from… | 2002 |
| * | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…Summary page 1…A &hexafocon A): K020006 * Boston XO (hexafocon A), Boston EQ (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses: K013762, K0531 24, K071043. 4. Description of device The Menicon Z lens material, tisilfocon A is a thermoset copolymer derived from fluorom… | 2006 |
| * | K071043 | Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas…Summary page 1…con A): K020006 * Boston XO (hexafocon A), Boston EQ (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses: K013762, K0531 24, K071043. 4. Description of device The Menicon Z lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacryla… | 2007 |
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 |
|---|---|---|---|
| K103561 | Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens | 2011 | 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?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K103561 (Menicon Co, Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013646.
How does its category compare?
All HQD devicesHQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HQD
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HQD
80in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQD
2in 2025
MAUDE reports naming product code HQD, 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 | 4 | 78 | 0 | 6 |
| 2008 | 5 | 100 | 0 | 8 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 26 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 7 | 119 | 0 | 1 |
| 2017 | 9 | 66 | 0 | 3 |
| 2018 | 5 | 53 | 0 | 0 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 3 | 123 | 0 | 3 |
| 2022 | 3 | 29 | 0 | 3 |
| 2023 | 3 | 77 | 0 | 8 |
| 2024 | 5 | 80 | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with non-diseased eyes.
The lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
The lenses may be disinfected using a chemical disinfection system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081443: Menicon Z Rigid Gas Permeable Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081443
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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