Optik K & R Inc. (contract manufacturer, Toronto Ontario, CA): 2 new FDA device listings, incl. lens, contact (other material) - daily
Optik K & R Inc. (Toronto Ontario, California): 2 new FDA device listings, incl. lens, contact (other material) - daily. Its amount of 2 is above the median of 2 (69th percentile). Dated 21 days ago, it is in the active follow-up window. Score 65/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,709 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 309 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Optik K & R Inc. |
| Owner / operator | OPTIK K & R Inc. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Toronto Ontario, CA |
| New listings | 2 |
| Devices | Lens, Contact (Other Material) - Daily; Lens, Contact (Orthokeratology) |
| Product codes | HQD, MUW |
| Device classes | Class II |
| Medical specialties | Ophthalmic |
| Brand names | EYESPACE BESPOKE |
| First new listing | 2026-10-15 |
| Latest new listing | 2026-10-15 |
| FDA registration number | 3004145084 |
| Registration expires | 2027-12-31 |
| amount percentile | 69th of 2,709 (median 2, 1.0x median) |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-10-15
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CA first): Icu Medical, Inc. (specification developer, San Clemente, CA · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Citest Diagnostics Inc. (repackager or relabeler, VANCOUVER · Cgbio USA, Inc. (repackager or relabeler, Irvine, CA) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Optik K & R Inc. and 310 California peers
- California DeviceEstablishmentPulse records like this one: 310
- Optik K & R Inc.'s amount: 69th percentile of 2,709 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every California peer: $62,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Optik K & R Inc. in Toronto Ontario, California?
Optik K & R Inc. (Toronto Ontario, CA), a contract manufacturer, added 2 FDA device listings on 2026-10-15.
How does Optik K & R Inc. compare to other California DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,709 records; the median is 2. It is 21 days old, still within a typical 45-day follow-up window.
Optik K & R Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Optik K & R Inc. | Toronto Ontario, CA | 2 | 69th | 2026-10-15 |
| Tecomet Inc. | Wilmington, MA | 3 | 77th | 2026-10-15 |
| Bard Shannon Limited | Humacao, PR | 3 | 77th | 2026-10-14 |
| Orchid Orthopedic Solutions Oregon, Inc. | Oregon City, OR | 3 | 77th | 2026-10-05 |
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- Orchid Orthopedic Solutions Oregon, Inc.
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DeviceEstablishmentPulse: Contract manufacturer DeviceEstablishmentPulse: Foreign establishment DeviceEstablishmentPulse: records in California
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.