Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
.Decimal, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211511 | decimal Bolus | .Decimal, LLC | 2021-07-01 | 48 | 0 |
| K192554 | decimal3D | .Decimal, LLC | 2019-12-13 | 87 | 0 |
| K173940 | Astroid Planning App | .Decimal, LLC | 2018-05-15 | 140 | 0 |
| K151369 | .decimal p.d | .Decimal, LLC | 2015-08-07 | 78 | 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