Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rand Scientific Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
148 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963856 | RAND NASAL PACKING | Rand Scientific Corp. | 1996-10-18 | 23 | 0 |
| K961081 | SPIRIT RIDGE SILICONE CARVING BLOCK | Rand Scientific Corp. | 1996-05-22 | 65 | 0 |
| K961057 | DURALASTIC SHEETING II | Rand Scientific Corp. | 1996-05-16 | 59 | 0 |
| K955777 | PMMA CLASIC | Rand Scientific Corp. | 1996-05-16 | 148 | 0 |
| K961071 | THE MAGNUM CHIN IMPLANT | Rand Scientific Corp. | 1996-04-19 | 32 | 0 |
| K961072 | PEC IMPLANT | Rand Scientific Corp. | 1996-04-19 | 32 | 0 |
| K961080 | MEDIAL MALAR IMPLANT | Rand Scientific Corp. | 1996-04-19 | 32 | 0 |
| K961124 | THE NAUTILUS | Rand Scientific Corp. | 1996-04-19 | 29 | 0 |
| K955366 | TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS | Rand Scientific Corp. | 1996-03-28 | 127 | 0 |
| K952165 | TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS | Rand Scientific Corp. | 1995-06-30 | 88 | 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