Cleared Traditional

POP-N-LOK SYRINGE (K946219) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K946219 · Retractable Technologies, Inc. · General Hospital
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Dec 1995
Decision
372d
Days
Class 2
Risk

K946219 is an FDA 510(k) clearance for the POP-N-LOK SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Retractable Technologies, Inc. (Lewisville, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Retractable Technologies, Inc. devices

Submission Details

510(k) Number K946219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1994
Decision Date December 28, 1995
Days to Decision 372 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
243d slower than avg
Panel avg: 129d · This submission: 372d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 39
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K946219.
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · Terumo Medical Corp. · Sep 2005
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
BECTON DICKINSON SYRINGE
K992734 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1999
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · Smith & Nephew, Inc. · May 1995