Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Randwal Instrument Co., Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
127 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873990 | IRAS EDS INTERFEROMETRIC STIMULATOR | Randwal Instrument Co., Inc. | 1988-02-05 | 127 | 0 |
| K873987 | IRAS GLARE TESTER | Randwal Instrument Co., Inc. | 1987-11-24 | 56 | 0 |
| K864012 | IRAS PERIMETER | Randwal Instrument Co., Inc. | 1986-12-12 | 58 | 0 |
| K853556 | LASER IRAS | Randwal Instrument Co., Inc. | 1985-11-01 | 67 | 0 |
| K842567 | PORTABLE ACUIOMETER | Randwal Instrument Co., Inc. | 1984-08-15 | 44 | 0 |
| K827577 | VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETE | Randwal Instrument Co., Inc. | 1983-01-24 | 35 | 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