Cleared Special

K072037 - CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML

K072037 is an FDA 510(k) clearance for CAREO SAFETY SYRINGE FOR U-100 INSULIN ..., manufactured by Life-Shield Products, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 14-day FDA review.

K072037 · Life-Shield Products, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K072037

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

MEG Device Classification - Class 2, Special Controls

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
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K072037.
JIERUI SYRINGES AND NEEDLES
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K072482 · Smiths Medical Asd, Inc. · Nov 2007
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
K070117 · Dolomite Biotech Sdn Bhd · Aug 2007
INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024
K070203 · Inviro Medical Devices, Inc. · Apr 2007
SAF-T-SYRINGE- 0.5 AND 1ML/CC
K063340 · Safety Medical International, Incorporated · Mar 2007
K072037 · CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
Download PDF FDA Summary Life-Shield Products,…