Cleared Traditional

K871965 - JMS NEEDLES AND JMS SYRINGES

K871965 is the FDA 510(k) clearance for JMS NEEDLES AND JMS SYRINGES by Jms Co., Ltd.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K871965 · Jms Co., Ltd. · General Hospital
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Sep 1987
Decision
108d
Days
Class 2
Risk

K871965 is an FDA 510(k) clearance for the JMS NEEDLES AND JMS SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Jms Co., Ltd. (Hiroshima, JP). The FDA issued a Cleared decision on September 4, 1987 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Jms Co., Ltd. devices

Submission Details

510(k) Number K871965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1987
Decision Date September 04, 1987
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 292
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K871965.
DISPOSABLE SYRINGE
K882335 · Baxter Healthcare Corp · Jun 1988
MEDSURG MYELOGRAM TRAY
K880693 · Medsurg Industries, Inc. · May 1988
ALLERGIST SYRINGES
K880894 · Abco Dealers, Inc. · Mar 1988
SAFETY SYRINGE
K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
MONOJECT PHARMACY TRAY
K860688 · Sherwood Medical Co. · Aug 1987
ADDITIVE EXTENSION SYRINGE
K853120 · Abbott Laboratories · Dec 1985