Cleared Traditional

K861390 - DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET

K861390 is an FDA 510(k) clearance for DEPTH MEASURING NEEDLES/VASCU IMPLANT A..., manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K861390 · Baxter Healthcare Corp · General Hospital
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Jul 1986
Decision
94d
Days
Class 2
Risk

K861390 is an FDA 510(k) clearance for the DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Hooksett, US). The FDA issued a Cleared decision on July 17, 1986 after a review of 94 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.

FDA 510(k) Submission Details - K861390

510(k) Number K861390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1986
Decision Date July 17, 1986
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
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 695
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K861390.
RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE
K864310 · Rymco Ltda · Jan 1987
BUTTERFLY NON-CORING NEEDLE SET
K863606 · Cormed, Inc., Sub. C.R.Bard, Inc. · Dec 1986
PROMEDICOR
K863514 · Terra Marketing Assoc. · Sep 1986
MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE
K861560 · Medi Point, Inc. · May 1986
ICU MEDICAL NEEDLE, LOPEZ NEEDLE
K860781 · Icu Medical, Inc. · May 1986
EXEL VACUUM BLOOD COLLECTING SYSTEM
K861152 · Exel Intl. · May 1986
K861390 · DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET
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