Cleared Special

K060208 - 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 is an FDA 510(k) clearance for CAREO SAFETY SYRINGE 1CC/ML, 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 42-day FDA review.

K060208 · Life-Shield Products, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
42d
Days
Class 2
Risk

K060208 is an FDA 510(k) clearance for the CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA019.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Life-Shield Products, Inc. (Taipei, TW). The FDA issued a Cleared decision on March 10, 2006 after a review of 42 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 - K060208

510(k) Number K060208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2006
Decision Date March 10, 2006
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 K060208.
RITRACT SAFETY SYRINGE
K060002 · Ritract , Ltd. · Jun 2006
OMI RETRACTABLE SAFETY SYRINGE
K060109 · Vitalcare Group, Inc. · May 2006
MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)
K060743 · Safety Syringes, Inc. · Apr 2006
CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
K052397 · Life-Shield Products, Inc. · Dec 2005
CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE
K051694 · Medical Device Manufacturer (Thailand) , Ltd. · Dec 2005
IN6 SAFETY SYRINGE, MODEL 3ML
K051800 · In6 Incuvestor, Inc. · Oct 2005
K060208 · CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
Download PDF FDA Summary Life-Shield Products,…