Cleared Traditional

K845043 - JMS NEEDLES & JMS SYRINGES

K845043 is the FDA 510(k) clearance for JMS NEEDLES & JMS SYRINGES by Jms Co., Ltd.. It is a Class 2 General Hospital device (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

Submission Details

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
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.

Device Classification

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 237
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
MONOJECT MENGHINI SOFT TISSUE BIOPSY
K843264 · Sherwood Medical Co. · Dec 1984
AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY
K842542 · American Pharmaseal Div. Ahsc · Aug 1984