Cleared Traditional

K911037 - SAFETY NEEDLE SHEATH, MODIFICATION

K911037 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 63-day FDA review.

K911037 · Concord/Portex · General Hospital
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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

FDA 510(k) Submission Details - K911037

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.

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 K911037.
MX927 BLOOD TRANSFER DEVICE
K913498 · Medex, Inc. · Nov 1991
MEGA MYELOGRAM KIT
K913141 · Megadyne Medical Products, Inc. · Oct 1991
MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE
K910733 · Medisystems Corp. · Jun 1991
VIAL ACCESS CANNULA
K905664 · Baxter Healthcare Corp · Mar 1991
SAFETY NEEDLE SHEATH
K904198 · Concord/Portex · Dec 1990
EXEL HUBER NEEDLE
K895769 · Exel Intl. · Feb 1990