Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smiths Medical Pm, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
150 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083557 | BCI WW1030 PULSE OXIMETER | Smiths Medical Pm, Inc. | 2009-05-01 | 150 | 0 |
| K090205 | BCI WW1021 PC APPLICATION | Smiths Medical Pm, Inc. | 2009-04-28 | 90 | 0 |
| K083787 | BCI WW1000 PULSE OXIMETER, MODEL WW1000 | Smiths Medical Pm, Inc. | 2009-04-15 | 117 | 0 |
| K083705 | BCI WW1020 PULSE OXIMETER, MODEL WW1020 | Smiths Medical Pm, Inc. | 2009-04-09 | 115 | 0 |
| K070732 | BCI AUTOCON 3304 DIGITAL PULSE OXIMETER | Smiths Medical Pm, Inc. | 2007-07-09 | 116 | 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