Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Microquartz Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
89 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955861 | MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER | Microquartz Medical, Inc. | 1996-01-26 | 30 | 0 |
| K954904 | MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER | Microquartz Medical, Inc. | 1996-01-22 | 89 | 0 |
| K953065 | ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) | Microquartz Medical, Inc. | 1995-09-27 | 89 | 0 |
| K952974 | QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER | Microquartz Medical, Inc. | 1995-08-28 | 62 | 0 |
| K953174 | MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY | Microquartz Medical, Inc. | 1995-08-28 | 52 | 0 |
| K950710 | MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER | Microquartz Medical, Inc. | 1995-03-10 | 25 | 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