# Sdi Diagnostics, Inc.

- Location (FDA's records): Easton, MA
- FDA decisions: 10 (1993–2016): 10 510(k) clearances
- Product codes: BZG (8), CAH (1), JAX (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 8 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Alliance Tech Medical, Inc.: 1 (https://510kreport.com/company/alliance-tech-medical)
- Pulmonary Data Services Inst., Inc.: 1 (https://510kreport.com/company/pulmonary-data-services-inst)
- Motion Media Technology, Inc.: 1 (https://510kreport.com/company/motion-media-technology)
- Ndd Medical Technologies: 1 (https://510kreport.com/company/ndd-medical-technologies)

## Firms that cite its devices most
- Mir Medical Intl. Research Srl: 2 (https://510kreport.com/company/mir-medical-intl-research)
- Fim Medical: 1 (https://510kreport.com/company/fim-medical)
- Cohero Health, LLC: 1 (https://510kreport.com/company/cohero-health)
- Pmd Healthcare: 1 (https://510kreport.com/company/pmd-healthcare)
- Dhd Healthcare Corp.: 1 (https://510kreport.com/company/dhd-healthcare)

## Its most-cited devices
- K934509: Pulmoguard Disposable Baterial/Viral Filter (1993), cited by 3
- K013812: Spirolab II, Model 29 (2002), cited by 2
- K031643: Spirotel, Model 29-1020 (2003), cited by 2
- K092813: Astrasonic Spirometer, Model 29-8000 (2010), cited by 1

## Recent decisions
- K150515: IQSense Flow Sensor Mouthpiece (Jan 12, 2016)
- K092813: Astrasonic Spirometer, Model 29-8000 (Jul 16, 2010)
- K061571: ASTRA 300 (Jan 31, 2007)
- K062913: Astraguard Pulmonary Function Filter (Jan 26, 2007)
- K033939: Flosense II, Model 29-8040 (Jan 30, 2004)
- K031643: Spirotel, Model 29-1020 (Dec 9, 2003)
- K013812: Spirolab II, Model 29 (Feb 11, 2002)
- K011470: Sdi SB Office, Model 29- (Oct 12, 2001)

Source page: https://510kreport.com/company/sdi-diagnostics