Cleared Traditional

K060743 - MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)

K060743 is an FDA 510(k) clearance for MODIFICATION TO: TAMPER EVIDENT ULTRASA..., manufactured by Safety Syringes, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K060743 · Safety Syringes, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
39d
Days
Class 2
Risk

K060743 is an FDA 510(k) clearance for the MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE .... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Safety Syringes, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 28, 2006 after a review of 39 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060743

510(k) Number K060743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date April 28, 2006
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K060743.
SAFE TIP SYRINGE
K060668 · Devon Safety Products, Inc. · Jun 2006
RITRACT SAFETY SYRINGE
K060002 · Ritract , Ltd. · Jun 2006
OMI RETRACTABLE SAFETY SYRINGE
K060109 · Vitalcare Group, Inc. · May 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
CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE
K051694 · Medical Device Manufacturer (Thailand) , Ltd. · Dec 2005
K060743 · MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)
Download PDF FDA Summary Safety Syringes, Inc.