Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rjl Systems, Inc. — 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) |
|---|---|---|---|---|---|
| K070999 | BC (BODY COMPOSITION SOFTWARE) | Rjl Systems, Inc. | 2007-08-02 | 115 | 0 |
| K911194 | IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-2000 | Rjl Systems, Inc. | 1991-09-30 | 196 | 0 |
| K862383 | MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER | Rjl Systems, Inc. | 1987-02-03 | 224 | 0 |
| K830292 | BIOELECTRICAL IMPEDANCE ANALYZER #101 | Rjl Systems, Inc. | 1983-08-12 | 197 | 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