Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd.
Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd.: 510(k) cleared for Menicon Co, Ltd. Its amount of 59 is below the median of 138 (16th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 59 · 16th percentile of 414 FDAPulse records · 0.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 9 related JP FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262495 |
| Device | Miru 1day UpSide (midafilcon A) |
| Applicant | Menicon Co, Ltd. |
| Specialty / panel | Ophthalmic |
| Product code | LPL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-20 |
| Decision date | 2026-09-17 |
| Review time (days) | 59 |
| Third-party review | No |
| Applicant location | Nagoya, JP |
| amount percentile | 16th of 414 (median 138, 0.4x median) |
| Peer records CSV (10 JP records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of JP records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co + all 10 JP records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-17
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (JP first): Lilium one (USM330) (K260605) · SCENARIA View Phase 6.0 (K261229) · APERTO Lucent MRI System (K261283) · KOWA FM-600 (K261255) · DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece ( · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd. and 10 JP peers
- JP FDAPulse records like this one: 10
- Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd.'s amount: 16th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every JP peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 59-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd.?
Miru 1day UpSide (midafilcon A) (K262495) by Menicon Co, Ltd. was cleared on 2026-09-17 after 59 days of review.
How does Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd. compare to other FDAPulse records?
Its amount of 59 is below the median (16th percentile); smaller records often move faster and face less competition. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
Miru 1day UpSide (midafilcon A) (K262495) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Miru 1day UpSide (midafilcon A) (K262495) | JP | 2026-09-17 |
| SLIT LAMP SL-D4 (Type | JP | 2026-09-18 |
| KOWA FM-600 (K261255) | JP | 2026-09-11 |
Related records
- OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens (K253875): 510(k) cleared for Visco Vision, Inc.
- ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH
- MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies
- Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc.
- SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation
- KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory
- B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)
- LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc.
- BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.
- Mobile Dental Solution (Model: DS50, DS70, DS90) (K260275): 510(k) cleared for Guangdong JINME Medical Technology Co., Ltd.
- Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230): 510(k) cleared for Suzhou Medical Appliance Factory
- Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Ophthalmic devices
How to monitor Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd. and peer ophthalmic records
Get new FDAPulse records like Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.