Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Health Systems Intl., 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) |
|---|---|---|---|---|---|
| K874232 | MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000 | Health Systems Intl., Inc. | 1989-03-10 | 512 | 0 |
| K881492 | MTI WOLFF SYSTEM, TANNING BED | Health Systems Intl., Inc. | 1988-04-19 | 11 | 0 |
| K881353 | MTI WOLFF SYSTEM | Health Systems Intl., Inc. | 1988-04-06 | 7 | 0 |
| K862372 | ULTRATAN TANNING SYSTEM | Health Systems Intl., Inc. | 1986-07-09 | 15 | 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