Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infinitech, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
358 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972506 | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | Infinitech, Inc. | 1997-10-01 | 90 | 0 |
| K971950 | INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER | Infinitech, Inc. | 1997-08-01 | 65 | 0 |
| K951627 | INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM | Infinitech, Inc. | 1995-10-19 | 195 | 0 |
| K931264 | INFINITECH OTOPROBE | Infinitech, Inc. | 1994-03-01 | 358 | 0 |
| K931546 | END-IRRIGATING ENDOILLUMINATOR | Infinitech, Inc. | 1994-02-09 | 317 | 0 |
| K935441 | INFINITECH BREATH EZ | Infinitech, Inc. | 1994-02-07 | 87 | 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