Data / Medical devices / United States / Laborie Medical Technologies Corp.
Laborie Medical Technologies Corp.: FDA-registered device maker in Portsmouth, NH, United States, 20 510(k) clearances
Laborie Medical Technologies Corp. is registered with the FDA (registration 3017448360) in Portsmouth, NH, United States. It lists 14 device types. The FDA files 20 510(k) clearances under its listings, the newest dated August 27, 2024. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017448360
- Address
- 180 International Drive, Portsmouth, NH, United States, 03801
- Owner or operator
- Laborie Medical Technologies Corp. (10079684)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 12, 2021
- Registered through
- 2027
- Brand names listed
- 4-Channel Perfusion Set, 4-Channel Radial ARM Catheter, 4-Channel Radial Anorectal Catheter, 8-Channel Perfusion Set, 8-Channel Radial Anorectal Catheter, Abdominal Pressure Catheter, Air-Charged Catheters, Air-Charged Reusable Cable and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cystometer, Electrical Recording | EXQ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Cystometric, Hydraulic | FEN | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Nerve Conduction Velocity Measurement | JXE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Esophageal Motility, Anorectal Motility, And Tube | KLA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Perineometer | HIR | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Gastrointestinal Motility (Electrical) | FFX | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Uroflowmeter | EXY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2024 | K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | FBK | Substantially Equivalent | Laborie Medical Technologies, Corp. | accessdata.fda.gov |
| May 6, 2024 | K240007 | Solar Compact (G4-1) | FFX | Substantially Equivalent | Laborie Medical Technologies, Corp. | accessdata.fda.gov |
| April 23, 2024 | K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | KLA | Substantially Equivalent | Laborie Medical Technologies, Corp. | accessdata.fda.gov |
| October 19, 2016 | K160081 | TENS Electrodes | GXY | Substantially Equivalent | Cathay Manufacturing Corp. | accessdata.fda.gov |
| August 1, 2012 | K121014 | SOLAR GI | FFX | Substantially Equivalent | Medical Measurement Systems B.V. | accessdata.fda.gov |
| July 21, 2009 | K090830 | LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP | FBK | Substantially Equivalent | Laborie Medical Technologies, Ltd. | accessdata.fda.gov |
| May 4, 2007 | K070331 | UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES | KPI | Substantially Equivalent | Laborie Medical Technologies | accessdata.fda.gov |
| March 15, 2007 | K062222 | UNITIP HIGH RESOLUTION CATHETER | FFX | Substantially Equivalent | Unisensor AG | accessdata.fda.gov |
| April 21, 2006 | K060166 | OHMEGA | FFX | Substantially Equivalent | Medical Measurement Systems B.V. | accessdata.fda.gov |
| December 15, 2005 | K052338 | SOLAR GI | FFX | Substantially Equivalent | Medical Measurement Systems B.V. | accessdata.fda.gov |
| May 26, 2005 | K050993 | MMS VIDEO OPTION | LLZ | Substantially Equivalent | Medical Measurement Systems B.V. | accessdata.fda.gov |
| March 19, 2004 | K031084 | SOLAR GI SYSTEM | FFX | Substantially Equivalent | Medical Measurement Systems B.V. | accessdata.fda.gov |
| March 3, 2004 | K031930 | HIGH SPEED EMG MODULE | GWF | Substantially Equivalent | Medical Measurement Systems B.V. | accessdata.fda.gov |
| July 31, 2001 | K003580 | UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER | FFX | Substantially Equivalent | Unisensor AG | accessdata.fda.gov |
| November 29, 1999 | K993721 | UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES | KPI | Substantially Equivalent | Laborie Medical Tech Corp. | accessdata.fda.gov |
| August 5, 1999 | K990041 | UROSTYM BIOFEEDBACK AND STIMULATION PROBES | KPI | Substantially Equivalent | Laborie Medical Tech Corp. | accessdata.fda.gov |
| June 5, 1997 | K963064 | ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM | FFX | Substantially Equivalent | Laborie Medical Tech Corp. | accessdata.fda.gov |
| May 20, 1997 | K962009 | UROSTYM | KPI | Substantially Equivalent | Laborie Medical Technologies, Ltd. | accessdata.fda.gov |
| March 30, 1995 | K950016 | CART, MODE NUMBER UDS-CART | FEN | Substantially Equivalent | Laborie Medical Tech Corp. | accessdata.fda.gov |
| July 12, 1994 | K942023 | INFUSION PUMP, MODEL NO. UDP-5 | FEN | Substantially Equivalent | Laborie Medical Technologies, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 21, 2026 | 98876 | Class II | Ongoing | Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HR | Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed. | accessdata.fda.gov |
| February 7, 2023 | 91831 | Class II | Ongoing | injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge | The packaging may be damaged, compromising the sterile barrier. | accessdata.fda.gov |
| July 17, 2019 | 83310 | Class II | Terminated | U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions | Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard | accessdata.fda.gov |
| April 9, 2009 | 52431 | Not yet classified | Terminated | Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr, 40cm For Cystometry. Catalog Number: CAT-206. | Laborie Medical Technologies reports that there was a mix up in the labeling and packaging of their Urodynamic Catheters. There were 8Fr catheters mixed inside the 6Fr catheter packages. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Gastrointestinal Motility (Electrical)
- All makers of Electrode, Cutaneous
- All makers of Stimulator, Electrical, Evoked Response
- All makers of Device, Nerve Conduction Velocity Measurement
- All makers of Device, Cystometric, Hydraulic
- All makers of Cable, Electrode
Updated July 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.