Cleared Traditional

BUTTERFLY NON-CORING NEEDLE SET (K863606) - FDA 510(k) Clearance

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

K863606 · Cormed, Inc., Sub. C.R.Bard, Inc. · General Hospital
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Dec 1986
Decision
93d
Days
Class 2
Risk

K863606 is an FDA 510(k) clearance for the BUTTERFLY NON-CORING NEEDLE SET. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Cormed, Inc., Sub. C.R.Bard, Inc. (Medina, US). The FDA issued a Cleared decision on December 18, 1986 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cormed, Inc., Sub. C.R.Bard, Inc. devices

Submission Details

510(k) Number K863606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date December 18, 1986
Days to Decision 93 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
36d faster than avg
Panel avg: 129d · This submission: 93d
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 196
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K863606.
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 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