Cleared Traditional

K213429 - AccuSert Needle Inserter

K213429 is an FDA 510(k) clearance for AccuSert Needle Inserter, manufactured by Emed Technologies Corporation. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K213429 · Emed Technologies Corporation · General Hospital
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Oct 2022
Decision
364d
Days
Class 2
Risk

K213429 is an FDA 510(k) clearance for the AccuSert Needle Inserter. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Emed Technologies Corporation (El Dorado Hills, US). The FDA issued a Cleared decision on October 20, 2022 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - 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 Emed Technologies Corporation devices

FDA 510(k) Submission Details - K213429

510(k) Number K213429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2021
Decision Date October 20, 2022
Days to Decision 364 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
235d slower than avg
Panel avg: 129d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
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 - KZH Introducer, Syringe Needle

All 8
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K213429.
GripMate
K243232 · Synthon Hispania S.L. · Dec 2024
MiniMed Quick-serter
K160860 · Medtronic Minimed · Sep 2016
QUICK-SERTER, MODEL 395
K992300 · Medtronic Minimed · Jul 1999
B-D AUTO-INJECTOR
K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
K970479 · Medtronic Minimed · Mar 1997
V-CATH PERCUTANEOUS INTRODUCER KIT
K951384 · Hdc Corp. · Jun 1995