Cleared Traditional

K884754 - VOYAGER/X

K884754 is an FDA 510(k) clearance for VOYAGER/X, manufactured by Smith-Perry Corp.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K884754 · Smith-Perry Corp. · Anesthesiology device
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Jan 1989
Decision
51d
Days
Class 2
Risk

K884754 is an FDA 510(k) clearance for the VOYAGER/X. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Smith-Perry Corp. (Riviera Beach, US). The FDA issued a Cleared decision on January 4, 1989 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory 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 Smith-Perry Corp. devices

FDA 510(k) Submission Details - K884754

510(k) Number K884754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date January 04, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 140d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - NFB Conserver, Oxygen

All 60
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K884754.
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K890141 · Devilbiss Health Care, Inc. · Apr 1989
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
K890298 · Salter Labs · Feb 1989
OXYMATIC-24
K884562 · Chad Therapeutics, Inc. · Jan 1989
BUNN MODEL 50 OXYGEN FLOW CONTROLLER
K883216 · The John Bunn Co. · Aug 1988
COMPANION MINI OXYGEN SAVER
K873901 · Puritan Bennett Corp. · Dec 1987
COMPANION OXYGEN SAVER
K863695 · Puritan Bennett Corp. · Oct 1986