Ulticare Safety Insulin Syringe

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K103011 ↗

FDA Product Code

MEG

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Absorbent Fiber

  Class I

  FDA 510(k) K914431 Active Cleared 4 Dec 1991

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  Class II

  FDA 510(k) K922828 Active Cleared 28 Sep 1992

• Surgical Instrument Kit, Disposable

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  FDA 510(k) K920989 Active Cleared 19 Oct 1992

• Absorbable Gauze Drape

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  FDA 510(k) K901465 Active Cleared 12 Jun 1990

• Post Operative Sponge

  Class I

  FDA 510(k) K912693 Active Cleared 4 Oct 1991

• Cover, Shoe Operating Room

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  FDA 510(k) K865023 Active Cleared 12 Jan 1987

See all devices from Ulti-Med Intl., Inc. →

• What is the Ulticare Safety Insulin Syringe used for?

  The Ulticare Safety Insulin Syringe is designed for the injection of U-100 insulin into the body. It is a safety-engineered syringe intended to help reduce the risk of needlestick injuries through its protective antistick mechanism, making it suitable for use in general hospital settings where insulin administration occurs.

• Is the Ulticare Safety Insulin Syringe reusable or single-use?

  The device is supplied as a single-use product, meaning it is intended for one injection only and should be discarded after use. This design supports infection control and safety by preventing reuse, which could compromise sterility or increase needlestick risk.

• How is the Ulticare Safety Insulin Syringe supplied and what safety feature does it include?

  The syringe is supplied as a single-use, sterile device and includes a safety-engineered antistick mechanism. This protective feature is designed to cover or retract the needle after use to help prevent accidental needlestick injuries to healthcare workers during handling or disposal.

• What regulatory pathway was used for the Ulticare Safety Insulin Syringe?

  The Ulticare Safety Insulin Syringe received FDA 510(k) clearance under k-number K103011, indicating it was found substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under regulation number 880.5860 with product code MEG.