Cleared Traditional

K863606 - BUTTERFLY NON-CORING NEEDLE SET

K863606 is an FDA 510(k) clearance for BUTTERFLY NON-CORING NEEDLE SET, manufactured by Cormed, Inc., Sub. C.R.Bard, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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

FDA 510(k) Submission Details - K863606

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.

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 527
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K863606.
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