Cleared Traditional

K132681 - SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE

K132681 is an FDA 510(k) clearance for SOL-GUARD INSULIN AND TUBERCULIN SAFETY..., manufactured by Sol-Millennium Medical, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K132681 · Sol-Millennium Medical, Inc. · General Hospital
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May 2014
Decision
267d
Days
Class 2
Risk

K132681 is an FDA 510(k) clearance for the SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Sol-Millennium Medical, Inc. (Lawrenceville, US). The FDA issued a Cleared decision on May 22, 2014 after a review of 267 days - an extended review 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: 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 Sol-Millennium Medical, Inc. devices

FDA 510(k) Submission Details - K132681

510(k) Number K132681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2013
Decision Date May 22, 2014
Days to Decision 267 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 129d · This submission: 267d
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 136
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K132681.
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
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K141664 · Rexam Healthcare · Oct 2014
NOVAGUARD S A SAFETY SYSTEM
K141464 · West Pharmaceutical Services · Sep 2014
TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE
K131531 · Anhui Tiankang Medical Products Co., Ltd. · May 2014
ULTRASAFE PLUS PASSIVE NEEDLE GUARD
K123743 · Safety Syringes, Inc. · Mar 2013
AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
K121637 · Sunwell Biotech Co., Ltd. · Oct 2012