Cleared Traditional

K845043 - JMS NEEDLES & JMS SYRINGES

K845043 is an FDA 510(k) clearance for JMS NEEDLES & JMS SYRINGES, manufactured by Jms Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K845043 · Jms Co., Ltd. · General Hospital
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Apr 1985
Decision
122d
Days
Class 2
Risk

K845043 is an FDA 510(k) clearance for the JMS NEEDLES & JMS SYRINGES. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Jms Co., Ltd. (Hiroshima, JP). The FDA issued a Cleared decision on April 29, 1985 after a review of 122 days - within the typical 510(k) review window.

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 Jms Co., Ltd. devices

FDA 510(k) Submission Details - K845043

510(k) Number K845043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1984
Decision Date April 29, 1985
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 129d · This submission: 122d
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 465
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K845043.
MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU
K854549 · Sherwood Medical Co. · Feb 1986
HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX
K853731 · Gish Biomedical, Inc. · Oct 1985
VASCULAR IMPLANT ACCESS NEEDLE SET
K851103 · Baxter Healthcare Corp · Jul 1985
CHURCHILL HABER POINT NEEDLE ADMIN. SET
K850420 · Churchill Corp. · Apr 1985
INFUSET W/HUBER NEEDLE
K844313 · Med Fusion Systems, Inc. · Jan 1985
MONOJECT MENGHINI SOFT TISSUE BIOPSY
K843264 · Sherwood Medical Co. · Dec 1984