Cleared Traditional

K904198 - SAFETY NEEDLE SHEATH

K904198 is an FDA 510(k) clearance for SAFETY NEEDLE SHEATH, manufactured by Concord/Portex. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K904198 · Concord/Portex · General Hospital
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Dec 1990
Decision
98d
Days
Class 2
Risk

K904198 is an FDA 510(k) clearance for the SAFETY NEEDLE SHEATH. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on December 19, 1990 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 880.5570 - 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: 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 Concord/Portex devices

FDA 510(k) Submission Details - K904198

510(k) Number K904198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date December 19, 1990
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
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.

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 322
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K904198.
MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE
K910733 · Medisystems Corp. · Jun 1991
SAFETY NEEDLE SHEATH, MODIFICATION
K911037 · Concord/Portex · May 1991
VIAL ACCESS CANNULA
K905664 · Baxter Healthcare Corp · Mar 1991
EXEL HUBER NEEDLE
K895769 · Exel Intl. · Feb 1990
EXEL SPINAL NEEDLES
K895771 · Exel Intl. · Feb 1990
B-D PEND NEEDLE
K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989