Cleared Traditional

K922158 - PROTECTOR SYRINGE SAFETY CAP SYSTEM

K922158 is an FDA 510(k) clearance for PROTECTOR SYRINGE SAFETY CAP SYSTEM, manufactured by Injectimed, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K922158 · Injectimed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
75d
Days
Class 2
Risk

K922158 is an FDA 510(k) clearance for the PROTECTOR SYRINGE SAFETY CAP SYSTEM. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Injectimed, Inc. (Ventura, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 75 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Injectimed, Inc. devices

FDA 510(k) Submission Details - K922158

510(k) Number K922158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1992
Decision Date July 21, 1992
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 354
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K922158.
B-D PEN NEEDLE
K924070 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA
K924439 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1993
LIFESHIELD VIAL ADAPTER
K920737 · Abbott Laboratories · Dec 1992
DISPOSABLE INTROSSEOUS INFUSION NEEDLES
K913258 · Cook, Inc. · Mar 1992
INTRAOSSEOUS ACCESS NEEDLE
K915409 · Cook, Inc. · Mar 1992
CHEMO-PORT
K913386 · Hdc Corp. · Jan 1992