Cleared Traditional

K873588 - 10CC CONTROL SYRINGE

K873588 is an FDA 510(k) clearance for 10CC CONTROL SYRINGE, manufactured by Medi-Plast Intl., Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K873588 · Medi-Plast Intl., Inc. · General Hospital
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Oct 1987
Decision
49d
Days
Class 2
Risk

K873588 is an FDA 510(k) clearance for the 10CC CONTROL SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medi-Plast Intl., Inc. (Roswell, US). The FDA issued a Cleared decision on October 23, 1987 after a review of 49 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.

FDA 510(k) Submission Details - K873588

510(k) Number K873588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1987
Decision Date October 23, 1987
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 681
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K873588.
DUOFLO DISPENSER
K872565 · Hemaedics, Inc. · Dec 1987
CUSTOM PROCEDURE TRAYS
K871616 · Medical Custom Products, Inc. · Dec 1987
3 RING ATTACHMENT FOR SYRINGES
K873709 · Condor Medical · Nov 1987
BAXA TUBING SETS (FOR PHARMACY PUMP)
K872743 · Baxa Corp., Sub. of Cook Group, Inc. · Oct 1987
NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM
K872805 · Squibb-Novo, Inc. · Oct 1987
JMS NEEDLES AND JMS SYRINGES
K871965 · Jms Co., Ltd. · Sep 1987
K873588 · 10CC CONTROL SYRINGE
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