Cleared Traditional

K911037 - SAFETY NEEDLE SHEATH

K911037 is the FDA 510(k) clearance for SAFETY NEEDLE SHEATH by Concord/Portex. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K911037 · Concord/Portex · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
63d
Days
Class 2
Risk

K911037 is an FDA 510(k) clearance for the SAFETY NEEDLE SHEATH, MODIFICATION. 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 May 3, 1991 after a review of 63 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 Concord/Portex devices

Submission Details

510(k) Number K911037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1991
Decision Date May 03, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 206
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K911037.
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
VIAL ACCESS CANNULA
K905664 · Baxter Healthcare Corp · Mar 1991
B-D PEND NEEDLE
K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 1988