Data / Medical devices / United States / Sdi Diagnostics, Inc.
Sdi Diagnostics, Inc.: FDA-registered device maker in South Easton, MA, United States, 5 510(k) clearances
Sdi Diagnostics, Inc. is registered with the FDA (registration 1220253) in South Easton, MA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 12, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1220253
- Address
- 10 Hampden Dr, South Easton, MA, United States, 02375
- Owner or operator
- SDI DIAGNOSTICS, INC (1220253)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 13, 2012
- Registered through
- 2026
- Brand names listed
- Astra BT, Astra300 Diagnostic spirometer, AstraTouch Diagnostic Spirometer, Astraguard, Filtrette, Filtrette A Bacterial Viral Filters, IQSense Spirometer Mouthpiece, Pulmoguard, Safe-t-Check, Oval, Accurette, Air Tube Mouthpiece, Spirobank
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 12, 2016 | K150515 | IQSense Flow Sensor Mouthpiece | BZG | Substantially Equivalent | Sdi Diagnostics, Inc. | accessdata.fda.gov |
| January 31, 2007 | K061571 | ASTRA 300 | BZG | Substantially Equivalent | Sdi Diagnostics, Inc. | accessdata.fda.gov |
| January 26, 2007 | K062913 | ASTRAGUARD PULMONARY FUNCTION FILTER | BZG | Substantially Equivalent | Sdi Diagnostics, Inc. | accessdata.fda.gov |
| December 21, 1998 | K983909 | MIR SPIROBANK SPIROMETER | BZG | Substantially Equivalent | Mir Medical Intl. Research Srl | accessdata.fda.gov |
| October 21, 1993 | K934509 | PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER | CAH | Substantially Equivalent | Sdi Diagnostics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Spirometer, Diagnostic
- All makers of Mouthpiece, Breathing
Updated January 12, 2016. 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.