Cleared Traditional

K881758 - VIGGO VASCUPORT NEEDLE

K881758 is the FDA 510(k) clearance for VIGGO VASCUPORT NEEDLE by Ohmeda Medical. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K881758 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1988
Decision
39d
Days
Class 2
Risk

K881758 is an FDA 510(k) clearance for the VIGGO VASCUPORT NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Ohmeda Medical (Tampa, US). The FDA issued a Cleared decision on June 3, 1988 after a review of 39 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ohmeda Medical devices

Submission Details

510(k) Number K881758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1988
Decision Date June 03, 1988
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 235
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K881758.
VIAL ACCESS CANNULA
K905664 · Baxter Healthcare Corp · Mar 1991
B-D PEND NEEDLE
K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 1988
BLOOD COLLECTING NEEDLE AND HOLDERS
K880892 · Abco Dealers, Inc. · Apr 1988
HR(TM) NEEDLE AND SYRINGE
K874372 · Icu Medical, Inc. · Nov 1987
HR (TM) COLLECTION SYSTEM
K872580 · Icu Medical, Inc. · Aug 1987