Cleared Traditional

K921797 - PRECI-JET 50

K921797 is an FDA 510(k) clearance for PRECI-JET 50, manufactured by Hmi Industries, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K921797 · Hmi Industries, Inc. · General Hospital
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Nov 1992
Decision
217d
Days
Class 2
Risk

K921797 is an FDA 510(k) clearance for the PRECI-JET 50. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Hmi Industries, Inc. (Rexdale, Ontario, CA). The FDA issued a Cleared decision on November 17, 1992 after a review of 217 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - 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.

FDA 510(k) Submission Details - K921797

510(k) Number K921797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date November 17, 1992
Days to Decision 217 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 129d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZE Device Classification - Class 2, Special Controls

Product Code KZE Injector, Fluid, Non-electrically Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5430
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 - KZE Injector, Fluid, Non-electrically Powered

All 52
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K921797.
MEDIVAX
K945548 · Vitajet Corp. · Nov 1995
HYPEX(TM) JET INJECTOR
K945873 · Equidyne Systems, Inc. · Aug 1995
BIOJECT JET INJECTION SYSTEM
K920631 · Bioject, Inc. · Jun 1994
OPHTHALMIC VISCOINJECTOR DRIVE
K923326 · Synergetics, Inc. · Sep 1992
MED-E-JET INJECTOR
K913018 · Med-E-Jet D · Sep 1991
INJECTOR, INSULIN
K905062 · Sound 2000 Medical Systems, Inc. · Mar 1991
K921797 · PRECI-JET 50
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