Data / Medical devices / Ophthalmic Syringe
Ophthalmic Syringe (QLY): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Ophthalmic Syringe (product code QLY, Class 2, 21 CFR 880.5860). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on November 21, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QLY
- Device class
- 2
- Regulation
- 880.5860
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 2 |
Makers of Ophthalmic Syringe
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Staclear, Inc. | Raleigh, NC, United States | Manufacturer | 3 | November 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Congruence Medical Solutions, LLC | Baltimore, MD, United States | Specification developer | 1 | December 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ocuject, LLC | San Diego, CA, United States | Specification developer | 1 | September 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Kindly Enterprise Development Group Co., Ltd. | JIADING Shanghai, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Kindly Medical Devices Co., Ltd | WENZHOU Zhejiang, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.