Sdi Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Sdi Diagnostics, Inc.” (first 1993, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 174 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 316 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 8 | 8 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| JAX | Pneumotachometer | 1 | 1 |
Review panels
- Anesthesiology (9)
- General Hospital (1)
Most recent Sdi Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150515 | IQSense Flow Sensor Mouthpiece | BZG | 2016-01-12 | 316 |
| K092813 | ASTRASONIC SPIROMETER, MODEL 29-8000 | BZG | 2010-07-16 | 305 |
| K061571 | ASTRA 300 | BZG | 2007-01-31 | 239 |
| K062913 | ASTRAGUARD PULMONARY FUNCTION FILTER | BZG | 2007-01-26 | 121 |
| K033939 | FLOSENSE II, MODEL 29-8040 | BZG | 2004-01-30 | 46 |
| K031643 | SPIROTEL, MODEL 29-1020 | BZG | 2003-12-09 | 196 |
| K013812 | SPIROLAB II, MODEL 29 | BZG | 2002-02-11 | 88 |
| K011470 | SDI SB OFFICE, MODEL 29- | BZG | 2001-10-12 | 151 |
| K990962 | FLOSENSE, MODEL 29-8010 | JAX | 2000-01-07 | 291 |
| K934509 | PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER | CAH | 1993-10-21 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Sdi Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sdi Diagnostics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Sdi Diagnostics, Inc.” (first 1993, latest 2016), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sdi Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sdi Diagnostics, Inc. is 174 days.
Which FDA product codes appear under Sdi Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 8); CAH (Filter, Bacterial, Breathing-Circuit, 1); JAX (Pneumotachometer, 1).
Next steps
- See all 10 Sdi Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZG, Sdi Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.