Cleared Traditional

K864747 - VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES

K864747 is an FDA 510(k) clearance for VARIOUS SYRINGES W/NEEDLES, manufactured by Jms Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K864747 · Jms Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
24d
Days
Class 2
Risk

K864747 is an FDA 510(k) clearance for the VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES. 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 December 29, 1986 after a review of 24 days - a notably fast clearance cycle.

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: 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 Jms Co., Ltd. devices

FDA 510(k) Submission Details - K864747

510(k) Number K864747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date December 29, 1986
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 492
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K864747.
SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT
K870518 · Surgitek · Apr 1987
ACCUPEN(R)
K870078 · Ulster Scientific, Inc. · Mar 1987
REFILLABLE SYRINGE
K864407 · Med Fusion Systems, Inc. · Jan 1987
USI AUTOJECT INSULIN SYRINGE
K864761 · Ulster Scientific, Inc. · Dec 1986
3 RING ATTACHMENT
K864555 · Professional Medical Services · Dec 1986
DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES
K861153 · Exel Intl. · Apr 1986