Cleared Traditional

PROMEDICOR (K863514) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K863514 · Terra Marketing Assoc. · General Hospital
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Sep 1986
Decision
16d
Days
Class 2
Risk

K863514 is an FDA 510(k) clearance for the PROMEDICOR. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Terra Marketing Assoc. (Salt Lake City, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 16 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 Terra Marketing Assoc. devices

Submission Details

510(k) Number K863514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date September 25, 1986
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 197
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K863514.
VIGGO VASCUPORT NEEDLE
K881758 · Ohmeda Medical · Jun 1988
BLOOD COLLECTING NEEDLE AND HOLDERS
K880892 · Abco Dealers, Inc. · Apr 1988
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
MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE
K854547 · Sherwood Medical Co. · Feb 1986
MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES
K854548 · Sherwood Medical Co. · Feb 1986