Data / Medical devices / United States / Escalon Medical Corp
Escalon Medical Corp: FDA-registered device maker in New Berlin, WI, United States, 1 510(k) clearance
Escalon Medical Corp is registered with the FDA (registration 2183477) in New Berlin, WI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 14, 1992. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2183477
- Address
- 2440 South 179TH ST., New Berlin, WI, United States, 53146
- Owner or operator
- ESCALON MEDICAL CORP (2183477)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 14, 2016
- Registered through
- 2026
- Brand names listed
- Universal Gas Mixing Kit, Universal Viscous Fluid Control Pack BL7600
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Pressure, Gas | BXX | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Ophthalmic | MRH | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 14, 1992 | K923397 | SINGLE DOSE GAS INJECTOR | BXX | Substantially Equivalent | Escalon Medical Trek | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 5, 2010 | 56610 | Not yet classified | Terminated | PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146: Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire, Sterile EO | The packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. Use of a non-sterile product increases risk of patient infection. This recall involes: Model 78050 18 Gauge PD Access Vascular Access Device, Model 78060 Extended 18 Gauge PD Access Vascular Access Device, Model 75010 18 Gauge SmartNeedle Va | accessdata.fda.gov |
Compare with other makers
Updated October 22, 2010. 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.