Cleared Traditional

K905305 - SAFE-SITE NEEDLE COVER

K905305 is an FDA 510(k) clearance for SAFE-SITE NEEDLE COVER, manufactured by North American Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K905305 · North American Medical Products, Inc. · General Hospital
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Feb 1991
Decision
76d
Days
Class 2
Risk

K905305 is an FDA 510(k) clearance for the SAFE-SITE NEEDLE COVER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by North American Medical Products, Inc. (Loudonville, US). The FDA issued a Cleared decision on February 12, 1991 after a review of 76 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 North American Medical Products, Inc. devices

FDA 510(k) Submission Details - K905305

510(k) Number K905305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date February 12, 1991
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 451
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K905305.
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
SAFETY NEEDLE SHEATH
K904198 · Concord/Portex · Dec 1990
EXEL HUBER NEEDLE
K895769 · Exel Intl. · Feb 1990
EXEL SPINAL NEEDLES
K895771 · Exel Intl. · Feb 1990