Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rand S.R.L. — 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) |
|---|---|---|---|---|---|
| K161613 | Hang&Go PAC | Rand S.R.L. | 2016-12-28 | 201 | 0 |
| K120026 | PERFORMER HT/ HANG&GO HT BASIC | Rand S.R.L. | 2012-05-08 | 126 | 0 |
| K070213 | PERFORMER CBP SYSTEM | Rand S.R.L. | 2007-03-21 | 58 | 1 |
| K052555 | MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB | Rand S.R.L. | 2006-03-15 | 180 | 1 |
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