Balance Ophthalmics, Inc. (specification developer, Sioux Falls, SD): 1 new FDA device listing, incl. applicator, negative pressure, external, ocular
Balance Ophthalmics, Inc. (Sioux Falls, South Dakota): 1 new FDA device listing, incl. applicator, negative pressure, external, ocular. Its amount of 1 is above the median of 1 (50th percentile). Dated 30 days ago, it is in the active follow-up window. Score 80/100. As of 2026-10-28, 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: 1 · 50th percentile of 2,570 DeviceEstablishmentPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related SD DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Balance Ophthalmics, Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Sioux Falls, SD, US |
| New listings | 1 |
| Devices | Applicator, Negative Pressure, External, Ocular |
| Product codes | QQJ |
| Device classes | Class II |
| Medical specialties | Ophthalmic |
| Brand names | FSYX(TM) Ocular Pressure Adjusting Pump |
| First new listing | 2026-10-06 |
| Latest new listing | 2026-10-06 |
| FDA registration number | 3027866078 |
| Registration expires | 2027-12-31 |
| amount percentile | 50th of 2,570 (median 1, 1.0x median) |
| Peer records CSV (4 SD records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-10-06
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Balance Ophthalmics, Inc. and 4 South Dakota peers
- South Dakota DeviceEstablishmentPulse records like this one: 4
- Balance Ophthalmics, Inc.'s amount: 50th percentile of 2,570 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every South Dakota peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
80 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Balance Ophthalmics, Inc. in Sioux Falls, South Dakota?
Balance Ophthalmics, Inc. (Sioux Falls, SD), a specification developer (outsources manufacturing), added 1 FDA device listing on 2026-10-06.
How does Balance Ophthalmics, Inc. compare to other South Dakota DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,570 records; the median is 1. It is 30 days old, still within a typical 45-day follow-up window. Its Score of 80/100 puts it among the stronger signals in this feed.
Balance Ophthalmics, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Balance Ophthalmics, Inc. | Sioux Falls, SD | 1 | 50th | 2026-10-06 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
| Ge Medical Systems, LLC | Waukesha, WI | 3 | 77th | 2026-10-06 |
| Align Technology, Inc. | San Jose, CA | 3 | 77th | 2026-09-30 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in South Dakota
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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.