Cleared Traditional

K901162 - STERIMATIC(TM) SAFETY NEEDLE

K901162 is an FDA 510(k) clearance for STERIMATIC(TM) SAFETY NEEDLE, manufactured by Sterimatic Worldwide, Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K901162 · Sterimatic Worldwide, Ltd. · General Hospital
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Sep 1990
Decision
199d
Days
Class 2
Risk

K901162 is an FDA 510(k) clearance for the STERIMATIC(TM) SAFETY NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sterimatic Worldwide, Ltd. (Stroud, Gloucestershire, GB). The FDA issued a Cleared decision on September 28, 1990 after a review of 199 days - an extended review 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: 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 Sterimatic Worldwide, Ltd. devices

FDA 510(k) Submission Details - K901162

510(k) Number K901162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1990
Decision Date September 28, 1990
Days to Decision 199 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
70d slower than avg
Panel avg: 129d · This submission: 199d
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 513
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K901162.
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
B-D PEND NEEDLE
K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989