Cleared Traditional

K890473 - NEEDLE GUARD(TM)

K890473 is an FDA 510(k) clearance for NEEDLE GUARD(TM), manufactured by Martech 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 62-day FDA review.

K890473 · Martech Medical Products, Inc. · General Hospital
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Apr 1989
Decision
62d
Days
Class 2
Risk

K890473 is an FDA 510(k) clearance for the NEEDLE GUARD(TM). Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Martech Medical Products, Inc. (Riverside, US). The FDA issued a Cleared decision on April 3, 1989 after a review of 62 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 Martech Medical Products, Inc. devices

FDA 510(k) Submission Details - K890473

510(k) Number K890473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1989
Decision Date April 03, 1989
Days to Decision 62 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
67d faster than avg
Panel avg: 129d · This submission: 62d
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 456
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K890473.
EXEL SPINAL NEEDLES
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B-D PEND NEEDLE
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SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE
K890926 · Meadox Surgimed, Inc. · Jun 1989
STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES
K884211 · Marquette Medical, Inc. · Oct 1988
WINGED NON-CORING NEEDLE SET
K884212 · Marquette Medical, Inc. · Oct 1988
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 1988