510(k) Report

FDA applicant

Laborie Medical Technologies, Ltd.

Williston, VT18 decisions1992–20241 recall

FDA records 18 decisions for Laborie Medical Technologies, Ltd. (Williston, VT) from 1992 to 2024: 18 510(k) clearances. Most are in product codes FEN (Device, Cystometric, Hydraulic) and KPI (Stimulator, Electrical, Non-Implantable, For…). Its devices cite 9 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Laborie Medical Technologies, Corp.”, “Laborie Medical Technologies”, “Laborie Medical Technologies, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Laborie Medical Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2024

2007: 12008: 22009: 22024: 3
2007high 3 (2024) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Laborie Medical Technologies, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Laborie Medical Technologies, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FENDevice, Cystometric, Hydraulic3decisions
  • KPIStimulator, Electrical, Non-Implantable, For Incontinence2decisions
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology2decisions
  • KPNAlarm, Conditioned Response Enuresis2decisions
  • KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube1decision
  • HIRPerineometer1decision

Also: LKY (1), FHA (1), EXQ (1), FAP (1), GWF (1), IYO (1).

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 20092cite it
  • K073552Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 20082cite it
  • K931574Advance Model Uds-AdvLaborie Medical Technologies, Ltd. · 19931cites it
  • K081781NUWAVLaborie Medical Technologies, Corp. · 20081cites it

What has FDA decided for it lately?

  • K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp. · 2024
  • K240007Solar Compact (G4-1)Laborie Medical Technologies, Corp. · 2024
  • K234107Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)Laborie Medical Technologies, Corp. · 2024
  • K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 20091 recall
  • K082614Evox Electro Diagnostic DeviceLaborie Medical Technologies, Inc. · 2009
  • K081781NUWAVLaborie Medical Technologies, Corp. · 2008
  • K073552Laborie Urodynamic System with Tetra AccessoryLaborie Medical Technologies, Corp. · 2008
  • K070331Urostym Biofeedback and Stimulation Device and AccessoriesLaborie Medical Technologies · 2007

All 11 as Laborie Medical Technologies, Ltd. →All 5 as Laborie Medical Technologies, Corp. →The one decision as Laborie Medical Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K090830injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length…Feb 7, 2023Class II

Other applicant names beginning “Laborie”

FDA records each applicant name separately; these may or may not be the same firm.

Laborie Medical Tech Corp. 6