Cleared Special

CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML (K072037) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K072037 · Life-Shield Products, Inc. · General Hospital
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Aug 2007
Decision
14d
Days
Class 2
Risk

K072037 is an FDA 510(k) clearance for the CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Life-Shield Products, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 8, 2007 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Life-Shield Products, Inc. devices

Submission Details

510(k) Number K072037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2007
Decision Date August 08, 2007
Days to Decision 14 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MEG Syringe, Antistick

All 162
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