Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
I-Rep, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
357 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930692 | LATHAM TABLE | I-Rep, Inc. | 1994-02-02 | 357 | 0 |
| K930691 | ACCUTRAC TRACTION UNIT | I-Rep, Inc. | 1993-07-22 | 162 | 0 |
| K861864 | MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT | I-Rep, Inc. | 1986-07-14 | 60 | 0 |
| K854947 | REHABILITATION TABLES | I-Rep, Inc. | 1986-01-03 | 24 | 0 |
| K851690 | ADJUSTABLE TREATMENT TABLES | I-Rep, Inc. | 1985-05-07 | 21 | 0 |
| K842268 | VACUPULSE VACUUM UNIT | I-Rep, Inc. | 1984-07-20 | 42 | 0 |
| K832940 | ROTAGYM | I-Rep, Inc. | 1983-11-07 | 70 | 0 |
| K822906 | PHYSICAL MEDICINE & REHABILITATION EQUIP | I-Rep, Inc. | 1982-10-15 | 16 | 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