Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rozinn Electronics, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
89 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061780 | TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM F | Rozinn Electronics, Inc. | 2006-09-15 | 81 | 0 |
| K042463 | HOLTER PLUS | Rozinn Electronics, Inc. | 2004-09-22 | 9 | 0 |
| K022540 | CARDIO ID+(RZ153+) | Rozinn Electronics, Inc. | 2002-10-24 | 84 | 0 |
| K021517 | ABP FOR WINDOWS | Rozinn Electronics, Inc. | 2002-07-24 | 75 | 0 |
| K020213 | NETLINK/NETSCAN | Rozinn Electronics, Inc. | 2002-04-05 | 73 | 0 |
| K903331 | ROZINN 151 | Rozinn Electronics, Inc. | 1990-10-22 | 89 | 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