Cleared Traditional

K861153 - DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES

K861153 is an FDA 510(k) clearance for DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES, manufactured by Exel Intl.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K861153 · Exel Intl. · General Hospital
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Apr 1986
Decision
28d
Days
Class 2
Risk

K861153 is an FDA 510(k) clearance for the DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Exel Intl. (Culver City, US). The FDA issued a Cleared decision on April 23, 1986 after a review of 28 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 Exel Intl. devices

FDA 510(k) Submission Details - K861153

510(k) Number K861153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1986
Decision Date April 23, 1986
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 494
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K861153.
VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES
K864747 · Jms Co., Ltd. · Dec 1986
USI AUTOJECT INSULIN SYRINGE
K864761 · Ulster Scientific, Inc. · Dec 1986
3 RING ATTACHMENT
K864555 · Professional Medical Services · Dec 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