Cleared Traditional

K864310 - RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE

K864310 is an FDA 510(k) clearance for RYMCO STERILE SINGLE-USE NEEDLE/SINGLE ..., manufactured by Rymco Ltda. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K864310 · Rymco Ltda · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
78d
Days
Class 2
Risk

K864310 is an FDA 510(k) clearance for the RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Rymco Ltda (Coral Gables, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Rymco Ltda devices

FDA 510(k) Submission Details - K864310

510(k) Number K864310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date January 20, 1987
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 528
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K864310.
NON-CORING HUBER TYPE NEEDLES
K873957 · Advantage Medical Systems, Inc. · Oct 1987
HR (TM) COLLECTION SYSTEM
K872580 · Icu Medical, Inc. · Aug 1987
ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE
K862610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET
K861390 · Baxter Healthcare Corp · Jul 1986
ICU MEDICAL NEEDLE, LOPEZ NEEDLE
K860781 · Icu Medical, Inc. · May 1986
EXEL VACUUM BLOOD COLLECTING SYSTEM
K861152 · Exel Intl. · May 1986