Cleared Traditional

K992300 - QUICK-SERTER, MODEL 395

K992300 is an FDA 510(k) clearance for QUICK-SERTER, manufactured by Medtronic Minimed. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K992300 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
21d
Days
Class 2
Risk

K992300 is an FDA 510(k) clearance for the QUICK-SERTER, MODEL 395. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on July 29, 1999 after a review of 21 days - a notably fast clearance cycle.

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

View all Medtronic Minimed devices

FDA 510(k) Submission Details - K992300

510(k) Number K992300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1999
Decision Date July 29, 1999
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 25
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K992300.
SHL DISPOSABLE AUTOINJECTOR
K050434 · Shl Medical, USA · Jun 2005
INNOJECT AUTO-INJECTOR
K042557 · Innoject, Inc. · Nov 2004
AUTOJET 2 (NON-FIXED NEEDLE TYPE)
K993385 · Owen Mumford USA, Inc. · Nov 1999
SOFTINJECT
K991680 · Androsystems Srl · Jun 1999
AUTO-INJECTOR, SURE-INJECT 2000
K981266 · Mighty Mo, Corp. · Jul 1998
B-D AUTO-INJECTOR
K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998