Cleared Traditional

K854563 - DISPOSABLE SYRINGES & NEEDLES

K854563 is an FDA 510(k) clearance for DISPOSABLE SYRINGES & NEEDLES, manufactured by Medelec Intl. Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K854563 · Medelec Intl. Corp. · General Hospital
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Dec 1985
Decision
25d
Days
Class 2
Risk

K854563 is an FDA 510(k) clearance for the DISPOSABLE SYRINGES & NEEDLES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medelec Intl. Corp. (Miami Beach, US). The FDA issued a Cleared decision on December 9, 1985 after a review of 25 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 Medelec Intl. Corp. devices

FDA 510(k) Submission Details - K854563

510(k) Number K854563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1985
Decision Date December 09, 1985
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
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 513
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K854563.
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
ADDITIVE EXTENSION SYRINGE
K853120 · Abbott Laboratories · Dec 1985
SPAN / AID SYRINGE
K854255 · Span-America Medical Systems, Inc. · Nov 1985
JMS LCC INSULIN SYRINGE
K853838 · Jms Co., Ltd. · Oct 1985