Cleared Traditional

K873957 - NON-CORING HUBER TYPE NEEDLES

K873957 is an FDA 510(k) clearance for NON-CORING HUBER TYPE NEEDLES, manufactured by Advantage Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K873957 · Advantage Medical Systems, Inc. · General Hospital
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Oct 1987
Decision
25d
Days
Class 2
Risk

K873957 is an FDA 510(k) clearance for the NON-CORING HUBER TYPE NEEDLES. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Advantage Medical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on October 23, 1987 after a review of 25 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 Advantage Medical Systems, Inc. devices

FDA 510(k) Submission Details - K873957

510(k) Number K873957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1987
Decision Date October 23, 1987
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
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 275
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K873957.
CHEMO-PORT NON-CORING NEEDLES
K873165 · Hdc Corp. · Dec 1987
HR(TM) NEEDLE AND SYRINGE
K874372 · Icu Medical, Inc. · Nov 1987
BLOOD NEEDLE HOLDER
K873569 · Sage Products, Inc. · Nov 1987
HR (TM) COLLECTION SYSTEM
K872580 · Icu Medical, Inc. · Aug 1987
ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE
K862610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET
K861390 · Baxter Healthcare Corp · Jul 1986