Cleared Traditional

K851103 - VASCULAR IMPLANT ACCESS NEEDLE SET

K851103 is an FDA 510(k) clearance for VASCULAR IMPLANT ACCESS NEEDLE SET, 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 119-day FDA review.

K851103 · Baxter Healthcare Corp · General Hospital
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Jul 1985
Decision
119d
Days
Class 2
Risk

K851103 is an FDA 510(k) clearance for the VASCULAR IMPLANT ACCESS NEEDLE 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 16, 1985 after a review of 119 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

FDA 510(k) Submission Details - K851103

510(k) Number K851103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1985
Decision Date July 16, 1985
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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 473
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K851103.
MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES
K854548 · Sherwood Medical Co. · Feb 1986
MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU
K854549 · Sherwood Medical Co. · Feb 1986
HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX
K853731 · Gish Biomedical, Inc. · Oct 1985
JMS NEEDLES & JMS SYRINGES
K845043 · Jms Co., Ltd. · Apr 1985
CHURCHILL HABER POINT NEEDLE ADMIN. SET
K850420 · Churchill Corp. · Apr 1985
INFUSET W/HUBER NEEDLE
K844313 · Med Fusion Systems, Inc. · Jan 1985