Laborie Medical Technologies, Ltd.: FDA clearances and approvals
Laborie Medical Technologies, Ltd. has 18 FDA 510(k) clearances (first 1992, latest 2024), across 13 product codes in 3 review panels. Median 510(k) review time: 84 days. Since 2017 its median was 119 days, against 149 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named Laborie Medical Technologies, Ltd. It is the industry lead sponsor of 7 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 3 | 119 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Laborie Medical Technologies, Ltd.'s cleared 510(k)s took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 149 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | 3 | 3 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 2 | 2 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | 2 |
| KPN | Alarm, Conditioned Response Enuresis | 2 | 2 |
| EXQ | Cystometer, Electrical Recording | 1 | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 | 1 |
| FHA | Clamp, Penile | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| HIR | Perineometer | 1 | 1 |
Plus 3 more product codes.
Review panels
- Gastroenterology and Urology (16)
- Neurology (1)
- Radiology (1)
Most recent Laborie Medical Technologies, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | FBK | 2024-08-27 | 90 |
| K240007 | Solar Compact (G4-1) | FFX | 2024-05-06 | 125 |
| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | KLA | 2024-04-23 | 119 |
| K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | FBK | 2009-07-21 | 117 |
| K082614 | EVOX ELECTRO DIAGNOSTIC DEVICE | GWF | 2009-03-06 | 178 |
| K081781 | NUWAV | IYO | 2008-07-09 | 15 |
| K073552 | LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY | FEN | 2008-03-05 | 78 |
| K070331 | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES | KPI | 2007-05-04 | 88 |
| K962009 | UROSTYM | KPI | 1997-05-20 | 363 |
| K955856 | TEX-AID BLUE | LKY | 1996-02-16 | 52 |
8 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2026-05-21.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Laborie Medical Technologies, Ltd. is the industry lead sponsor of 7 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06905808: e-Sense® Normal Values of Urodynamic Pressures Using e-Sense® Catheters (Recruiting, started 2025-08-15)
- NCT04438499: e۰Sense® Catheter Clinical Investigation (Completed, started 2020-06-16)
- NCT03615001: T-DOC® NXT Clinical Investigation (Completed, started 2018-07-18)
- NCT03429270: T-DOC® 5 Fr Pediatric Clinical Investigation (Completed, started 2018-01-22)
- NCT02756182: Air-charged vs Water-filled Catheters (Bonn) (Completed, started 2016-04-27)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Laborie Medical Technologies, Ltd.'s product codes (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Frequently asked questions
How many FDA 510(k) clearances does Laborie Medical Technologies, Ltd. have?
Laborie Medical Technologies, Ltd. has 18 FDA 510(k) clearances (first 1992, latest 2024), across 13 product codes in 3 review panels.
How long does FDA take to clear Laborie Medical Technologies, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Laborie Medical Technologies, Ltd.'s cleared 510(k)s is 84 days. Since 2017: 119 days, versus 149 days for all cleared 510(k)s in the same product codes.
What devices does Laborie Medical Technologies, Ltd. make?
Its most frequent FDA product codes are FEN (Device, Cystometric, Hydraulic, 3); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 2); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 2).
Has Laborie Medical Technologies, Ltd. had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Laborie Medical Technologies, Ltd; the most recent began 2026-05-21. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 18 Laborie Medical Technologies, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FEN, Laborie Medical Technologies, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.