Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Research Instruments , Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
264 daysmedian FDA review time
356 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141434 | SATURN 5 LASER | Research Instruments , Ltd. | 2015-02-18 | 264 | 0 |
| K133257 | BIOPSY PIPETTES | Research Instruments , Ltd. | 2014-05-16 | 205 | 0 |
| K112413 | RI MSC (MIGRATION SEDIMENTATION CHAMBER) | Research Instruments , Ltd. | 2012-07-13 | 326 | 0 |
| K083208 | SATURN ACTIVE LASER SYSTEM | Research Instruments , Ltd. | 2009-08-25 | 298 | 0 |
| K060764 | SATURN 3 LASER SYSTEM | Research Instruments , Ltd. | 2007-03-12 | 356 | 0 |
| K003142 | MICROMANIPULATOR | Research Instruments , Ltd. | 2000-11-22 | 43 | 0 |
| K991261 | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLD | Research Instruments , Ltd. | 1999-08-05 | 114 | 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