Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laborie Medical Technologies, Ltd. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
363 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDG | Laborie Medical Technologies, Ltd. | 2009-07-21 | 117 | 1 |
| K962009 | UROSTYM | Laborie Medical Technologies, Ltd. | 1997-05-20 | 363 | 0 |
| K955856 | TEX-AID BLUE | Laborie Medical Technologies, Ltd. | 1996-02-16 | 52 | 0 |
| K955810 | U-TEX | Laborie Medical Technologies, Ltd. | 1996-01-24 | 29 | 0 |
| K951805 | PIPER, MODEL NUMBER UDS-PIPERB | Laborie Medical Technologies, Ltd. | 1995-07-06 | 79 | 0 |
| K942563 | ELITE BIOFEEDBACK | Laborie Medical Technologies, Ltd. | 1995-06-06 | 371 | 0 |
| K942023 | INFUSION PUMP, MODEL NO. UDP-5 | Laborie Medical Technologies, Ltd. | 1994-07-12 | 77 | 0 |
| K934369 | DRI SLEEPER | Laborie Medical Technologies, Ltd. | 1993-11-24 | 78 | 0 |
| K931574 | ADVANCE MODEL UDS-ADV | Laborie Medical Technologies, Ltd. | 1993-08-05 | 128 | 0 |
| K930005 | DRITRAINER | Laborie Medical Technologies, Ltd. | 1993-03-03 | 58 | 0 |
| K924086 | NICKI, MODEL NUMBER USD-NK-UP1 | Laborie Medical Technologies, Ltd. | 1992-10-20 | 68 | 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