Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QOG · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
427 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243901 | SmartPilot YpsoMate NS-A2.25 | Ypsomed AG | 2025-08-28 | 252 | 0 |
| K251500 | MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production | 2025-06-09 | 25 | 0 |
| K250555 | MallyaD injection pen adapter (MallyaD) | Biocorp Production | 2025-03-27 | 30 | 0 |
| K241803 | INSULCLOCK® v2.0 PRO | Insulcloud S.L. | 2024-08-22 | 62 | 0 |
| K231820 | SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production | 2024-01-12 | 205 | 0 |
| K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®) | Biocorp Production | 2022-12-05 | 90 | 0 |
| K212217 | Tempo Smart Button | Eli Lilly and Company | 2022-09-16 | 427 | 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