# Laborie Medical Technologies, Ltd.

- Location (FDA's records): Williston, VT
- FDA decisions: 18 (1992–2024): 18 510(k) clearances
- Names in FDA's records: Laborie Medical Technologies, Ltd. (11); Laborie Medical Technologies, Corp. (5); Laborie Medical Technologies (1); Laborie Medical Technologies, Inc. (1)
- Product codes: FEN (3), KPI (2), FBK (2), KPN (2), KLA (1), HIR (1), LKY (1), FHA (1), EXQ (1), FAP (1), GWF (1), IYO (1)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 6 (2 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medical Measurement Systems B.V.: 2 (https://510kreport.com/company/medical-measurement-systems)
- Physion, Inc.: 1 (https://510kreport.com/company/physion)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)
- Clinical Innovations, Inc.: 1 (https://510kreport.com/company/clinical-innovations)
- Mckenna & Cuneo: 1 (https://510kreport.com/company/mckenna-cuneo)
- Cadwell Laboratories, Inc.: 1 (https://510kreport.com/company/cadwell-laboratories)

## Firms that cite its devices most
- Srs Medical: 1 (https://510kreport.com/company/srs-medical)
- Urodynamix Technologies, Ltd.: 1 (https://510kreport.com/company/urodynamix-technologies)
- Halo Medical Technologies, LLC: 1 (https://510kreport.com/company/halo-medical-technologies)
- Uro-1, Inc.: 1 (https://510kreport.com/company/uro-1)

## Its most-cited devices
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (2009), cited by 2
- K073552: Laborie Urodynamic System with Tetra Accessory (2008), cited by 2
- K931574: Advance Model Uds-Adv (1993), cited by 1
- K081781: NUWAV (2008), cited by 1

## Recent decisions
- K241523: injeTAK Adjustable Tip Needle (DIS199; DIS201) (Aug 27, 2024)
- K240007: Solar Compact (G4-1) (May 6, 2024)
- K234107: Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (Apr 23, 2024)
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (Jul 21, 2009)
- K082614: Evox Electro Diagnostic Device (Mar 6, 2009)
- K081781: NUWAV (Jul 9, 2008)
- K073552: Laborie Urodynamic System with Tetra Accessory (Mar 5, 2008)
- K070331: Urostym Biofeedback and Stimulation Device and Accessories (May 4, 2007)

Source page: https://510kreport.com/company/laborie-medical-technologies