Laborie Medical Tech Corp.: FDA clearances and approvals
Laborie Medical Tech Corp. has 6 FDA 510(k) clearances (first 1994, latest 1999), across 5 product codes in 1 review panel. Median 510(k) review time: 78 days.
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 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 2 | 2 |
| EXY | Uroflowmeter | 1 | 1 |
| FEN | Device, Cystometric, Hydraulic | 1 | 1 |
| FFX | System, Gastrointestinal Motility (Electrical) | 1 | 1 |
| LIL | Monitor, Penile Tumescence | 1 | 1 |
Review panels
Most recent Laborie Medical Tech Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993721 | UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES | KPI | 1999-11-29 | 26 |
| K990041 | UROSTYM BIOFEEDBACK AND STIMULATION PROBES | KPI | 1999-08-05 | 211 |
| K991479 | VISER PENILE TUMESCENCE MONITOR | LIL | 1999-07-07 | 70 |
| K963064 | ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM | FFX | 1997-06-05 | 302 |
| K950016 | CART, MODE NUMBER UDS-CART | FEN | 1995-03-30 | 86 |
| K941105 | UORCAP,MODEL NUMBER UDS-UCAP | EXY | 1994-05-10 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Laborie Medical Tech Corp..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Laborie Medical Tech Corp.'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 Tech Corp. have?
Laborie Medical Tech Corp. has 6 FDA 510(k) clearances (first 1994, latest 1999), across 5 product codes in 1 review panel.
How long does FDA take to clear Laborie Medical Tech Corp.'s 510(k)s?
The median time from FDA receipt to decision across Laborie Medical Tech Corp.'s cleared 510(k)s is 78 days.
What devices does Laborie Medical Tech Corp. make?
Its most frequent FDA product codes are KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 2); EXY (Uroflowmeter, 1); FEN (Device, Cystometric, Hydraulic, 1).
Has Laborie Medical Tech Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Laborie Medical Tech Corp. Related entities may recall under other names.
Next steps
- See all 6 Laborie Medical Tech Corp. clearances with predicates and recalls
- Run predicate analysis for product code KPI, Laborie Medical Tech Corp.'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.