Cleared Traditional

K864778 - MACLEE/BOIN MEDICA STERILE NEEDLE/SYRIN...

K864778 is the FDA 510(k) clearance for MACLEE/BOIN MEDICA STERILE NEEDLE/SYRIN... by Mac Lee Medical Products. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K864778 · Mac Lee Medical Products · General Hospital
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Dec 1986
Decision
21d
Days
Class 2
Risk

K864778 is an FDA 510(k) clearance for the MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Mac Lee Medical Products (Topeka, US). The FDA issued a Cleared decision on December 29, 1986 after a review of 21 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 Mac Lee Medical Products devices

Submission Details

510(k) Number K864778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1986
Decision Date December 29, 1986
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 294
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K864778.
ALLERGIST SYRINGES
K880894 · Abco Dealers, Inc. · Mar 1988
SAFETY SYRINGE
K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
MONOJECT PHARMACY TRAY
K860688 · Sherwood Medical Co. · Aug 1987
ADDITIVE EXTENSION SYRINGE
K853120 · Abbott Laboratories · Dec 1985
MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
K852544 · Sherwood Medical Co. · Jul 1985
MONOJECT STERILE 60CC SYRINGES
K852580 · Sherwood Medical Co. · Jul 1985