Cleared Traditional

K060109 - OMI RETRACTABLE SAFETY SYRINGE

K060109 is an FDA 510(k) clearance for OMI RETRACTABLE SAFETY SYRINGE, manufactured by Vitalcare Group, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K060109 · Vitalcare Group, Inc. · General Hospital
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May 2006
Decision
112d
Days
Class 2
Risk

K060109 is an FDA 510(k) clearance for the OMI RETRACTABLE SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Vitalcare Group, Inc. (Deer Field, US). The FDA issued a Cleared decision on May 5, 2006 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitalcare Group, Inc. devices

FDA 510(k) Submission Details - K060109

510(k) Number K060109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2006
Decision Date May 05, 2006
Days to Decision 112 days
Submission Type Traditional
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
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 122
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K060109.
CAREO SAFETY SYRINGE FOR U-100 INSULIN
K061055 · Life-Shield Products, Inc. · Jul 2006
SAFE TIP SYRINGE
K060668 · Devon Safety Products, Inc. · Jun 2006
RITRACT SAFETY SYRINGE
K060002 · Ritract , Ltd. · Jun 2006
MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)
K060743 · Safety Syringes, Inc. · Apr 2006
CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
K060208 · Life-Shield Products, Inc. · Mar 2006
CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
K052397 · Life-Shield Products, Inc. · Dec 2005