BETA
Medical-device developer working on needle-free pharmaceutical vial access and medication-preparation systems for integration with pharmaceutical filling and finishing.
Klim-Loc Medical, Inc. develops proprietary needle-free medication-preparation and access technologies. Its company profile identifies Aspen, Colorado as its headquarters and 2016 as its founding year. The business was founded by flight paramedic Robbie Klimek and is led by CEO Daniel McMahon, MD.
The lead development program is a vial closure designed to connect to standard Luer-lock syringes, allowing medication withdrawal without a fill needle. Klim-Loc describes integration during pharmaceutical filling and finishing and a business model involving pharmaceutical partners and licensing.
Klim-Loc also describes a future spikeless, needleless IV fluid bag and infusion-set program. Its website discusses advancing toward FDA clearance and a Type III Drug Master File submission. Completed U.S. marketing authorization and commercial launch have not been established for the displayed programs.
Klim-Loc describes advancing toward FDA clearance and a Type III Drug Master File submission. These are stated objectives; the reviewed sources do not establish a completed submission or U.S. marketing authorization. A planned DMF submission is not itself device marketing authorization. [3]
The company’s PDA 2026 human-factors poster describes formative evaluation ahead of verification, validation and regulatory submission. A completed commercial launch has not been established in the reviewed sources. [8][6][11]
The IV bag and infusion-set concept is separately described as future product expansion. Proposed sensor integration and automatic electronic-record capture are development concepts; deployed sensor functionality, clinical performance and system integrations have not been established in the reviewed evidence. [7][11]
Published FDA applicant/firm and product-name searches found no matching 510(k) clearances, De Novo grants, original PMA approvals or recall events for Klim-Loc. [14][15][16][17]
Latest recorded source review: 2026-10-27.
No commercially marketed product portfolio has been established in the reviewed material.
Klim-Loc identifies Gilero as a development collaborator and describes a commercialization strategy focused on pharmaceutical integration and licensing. [5][3]
The Pharmapack organizer documented Highly Commended recognition for Klim-Loc’s vial-and-cap system in the 2024 Eco-design awards. A February 2025 Department of Justice notice separately lists Klim-Loc among added RRPV consortium members. [9][10][13]
A proprietary closure with a luer-activated septum, designed to permit medication withdrawal using a standard Luer-lock syringe without a fill needle. Company illustration shows the proposed vial-and-syringe assembly. [2][3][5][8]
Company-reported future program using a threaded bag port for infusion-set coupling and a needleless accessory port for syringe access. The company describes a working prototype and patent filing; these milestones are not independently confirmed. [7]
A Department of Justice notice listed Klim-Loc Medical among members added to the Rapid Response Partnership Vehicle consortium. [13]
Accessed 10/29/2026
Last substantive review: 10/27/2026