Cleared Traditional

K895811 - SHARGHP HYPODERMIC NEEDLE

K895811 is an FDA 510(k) clearance for SHARGHP HYPODERMIC NEEDLE, manufactured by Shargh Pharmaceutical Co., Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K895811 · Shargh Pharmaceutical Co., Inc. · General Hospital
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Sep 1990
Decision
343d
Days
Class 2
Risk

K895811 is an FDA 510(k) clearance for the SHARGHP HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Shargh Pharmaceutical Co., Inc. (Culver City, US). The FDA issued a Cleared decision on September 7, 1990 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Shargh Pharmaceutical Co., Inc. devices

FDA 510(k) Submission Details - K895811

510(k) Number K895811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1989
Decision Date September 07, 1990
Days to Decision 343 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
214d slower than avg
Panel avg: 129d · This submission: 343d
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 264
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K895811.
MX927 BLOOD TRANSFER DEVICE
K913498 · Medex, Inc. · Nov 1991
MEGA MYELOGRAM KIT
K913141 · Megadyne Medical Products, Inc. · Oct 1991
VIAL ACCESS CANNULA
K905664 · Baxter Healthcare Corp · Mar 1991
B-D PEND NEEDLE
K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 1988
VIGGO VASCUPORT NEEDLE
K881758 · Ohmeda Medical · Jun 1988