Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laborie Medical Technologies, Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
125 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Laborie Medical Technologies, Corp. | 2024-08-27 | 90 | 0 |
| K240007 | Solar Compact (G4-1) | Laborie Medical Technologies, Corp. | 2024-05-06 | 125 | 0 |
| K234107 | Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L | Laborie Medical Technologies, Corp. | 2024-04-23 | 119 | 0 |
| K081781 | NUWAV | Laborie Medical Technologies, Corp. | 2008-07-09 | 15 | 0 |
| K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | Laborie Medical Technologies, Corp. | 2008-03-05 | 78 | 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