Cleared Traditional

K861390 - DEPTH MEASURING NEEDLES/VASCU IMPLANT A...

K861390 is the FDA 510(k) clearance for DEPTH MEASURING NEEDLES/VASCU IMPLANT A... by Baxter Healthcare Corp. It is a Class 2 General Hospital device (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.

View all Baxter Healthcare Corp devices

Submission Details

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.

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 242
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K861390.
BLOOD NEEDLE HOLDER
K873569 · Sage Products, Inc. · Nov 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
ICU MEDICAL NEEDLE, LOPEZ NEEDLE
K860781 · Icu Medical, Inc. · May 1986
DISPOSABLE NEEDLE COUNTER (20-720)
K861318 · Anago, Inc. · May 1986
BLOOD COLLECTING NEEDLE
K855248 · Churchill Corp. · Feb 1986