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Profoject™ Insulin Syringes - Profoject™ Insulin Syringes

by CMT Health PTE., Ltd.

510(k) K253068

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253068 Date23 Feb 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Models / Variants
Profoject™ Insulin Syringes
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Profoject Insulin Syringes and Profoject Safelock Disposable Insulin Syringe are disposable, piston-driven insulin delivery devices designed for subcutaneous administration of insulin. These syringes feature a Safelock mechanism to prevent accidental needle sticks and ensure secure attachment of the needle, enhancing user safety and ease of use.

These syringes are intended for single-use in clinical and home settings, including general hospital environments. They are classified under FDA product code FMF and received FDA 510(k) clearance as substantially equivalent, with approval number K253068. No specific sterility or MRI safety information is provided in the data, and sizes or additional specifications are not detailed beyond the disposable, piston-type design.

Other devices from CMT Health PTE., Ltd.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Profoject Insulin Syringes and how does the Safelock mechanism improve safety during use?

    The Profoject Insulin Syringes are disposable, piston-driven devices designed specifically for subcutaneous insulin administration in both clinical and home settings. The Safelock mechanism enhances safety by preventing accidental needle sticks and ensuring a secure attachment of the needle, reducing the risk of exposure during use.

  • Are these syringes intended for reuse or single-use, and in what environments are they approved for use?

    These syringes are explicitly designed for single-use only, suitable for both hospital and home settings. The FDA clearance under product code FMF (General Hospital) confirms their approval for use in clinical environments, though the same design also supports home administration.

  • How were these syringes classified by the FDA, and what does ‘substantially equivalent’ mean in this context?

    The Profoject syringes were classified as substantially equivalent (SESE) by the FDA under a traditional 510(k) review process. This means the FDA determined they have the same intended use, technological characteristics, and performance as a legally marketed predicate device, ensuring they meet regulatory standards without requiring a full de novo classification.

  • What details are known about the manufacturing and regulatory submission process for these syringes?

    The syringes were submitted to the FDA by CMT Health PTE., Ltd. in Singapore, with the submission received on September 22, 2025, and cleared on February 23, 2026 (K253068). The submission was reviewed by the Orthopaedics and Rehabilitation Devices Panel (HO) and involved a third-party review, indicating a thorough evaluation process.