Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sdi Diagnostics, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
196 daysmedian FDA review time
316 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150515 | IQSense Flow Sensor Mouthpiece | Sdi Diagnostics, Inc. | 2016-01-12 | 316 | 0 |
| K092813 | ASTRASONIC SPIROMETER, MODEL 29-8000 | Sdi Diagnostics, Inc. | 2010-07-16 | 305 | 0 |
| K061571 | ASTRA 300 | Sdi Diagnostics, Inc. | 2007-01-31 | 239 | 0 |
| K062913 | ASTRAGUARD PULMONARY FUNCTION FILTER | Sdi Diagnostics, Inc. | 2007-01-26 | 121 | 0 |
| K033939 | FLOSENSE II, MODEL 29-8040 | Sdi Diagnostics, Inc. | 2004-01-30 | 46 | 0 |
| K031643 | SPIROTEL, MODEL 29-1020 | Sdi Diagnostics, Inc. | 2003-12-09 | 196 | 0 |
| K013812 | SPIROLAB II, MODEL 29 | Sdi Diagnostics, Inc. | 2002-02-11 | 88 | 0 |
| K011470 | SDI SB OFFICE, MODEL 29- | Sdi Diagnostics, Inc. | 2001-10-12 | 151 | 0 |
| K990962 | FLOSENSE, MODEL 29-8010 | Sdi Diagnostics, Inc. | 2000-01-07 | 291 | 0 |
| K934509 | PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER | Sdi Diagnostics, Inc. | 1993-10-21 | 37 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda