Cleared Traditional

K864900 - VIGGO EXACTA PRESSURE MONITORING KIT

K864900 is an FDA 510(k) clearance for VIGGO EXACTA PRESSURE MONITORING KIT, manufactured by Ohmeda Medical. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K864900 · Ohmeda Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
107d
Days
Class 2
Risk

K864900 is an FDA 510(k) clearance for the VIGGO EXACTA PRESSURE MONITORING KIT. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Ohmeda Medical (Tampa, US). The FDA issued a Cleared decision on April 1, 1987 after a review of 107 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K864900

510(k) Number K864900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1986
Decision Date April 01, 1987
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMG Device Classification - Class 2, Special Controls

Product Code FMG Stopcock, I.v. Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FMG Stopcock, I.v. Set

All 53
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K864900.
ADVANCE DISPOSABLE STOPCOCK
K902724 · Advance Medical Designs, Inc. · Dec 1990
TERUFUSION THREE WAY STOPCOCK
K891234 · Terumo Medical Corp. · Sep 1989
CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
K884463 · Ohmeda Medical · Jan 1989
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · Ohmeda Medical · Apr 1987
CHURCHILL 3-WAY STOPCOCK
K864440 · Churchill Corp. · Jan 1987
EXEL THREE-WAY STOPCOCK
K862492 · Exel Intl. · Sep 1986