Cleared Traditional

K981266 - AUTO-INJECTOR, SURE-INJECT 2000

K981266 is an FDA 510(k) clearance for AUTO-INJECTOR, manufactured by Mighty Mo, Corp.. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K981266 · Mighty Mo, Corp. · General Hospital
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Jul 1998
Decision
98d
Days
Class 2
Risk

K981266 is an FDA 510(k) clearance for the AUTO-INJECTOR, SURE-INJECT 2000. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Mighty Mo, Corp. (St. Petersburg, US). The FDA issued a Cleared decision on July 14, 1998 after a review of 98 days - within the typical 510(k) review window.

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. 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 Mighty Mo, Corp. devices

FDA 510(k) Submission Details - K981266

510(k) Number K981266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1998
Decision Date July 14, 1998
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 129d · This submission: 98d
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 12
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K981266.
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K974171 · Teva Medical, Ltd. · Dec 1997
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
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