Cleared Traditional

K854571 - DEMAND FLOW VALVE & SONRA W/NASAL MASK

K854571 is an FDA 510(k) clearance for DEMAND FLOW VALVE & SONRA W/NASAL MASK, manufactured by Gale E. Dryden. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K854571 · Gale E. Dryden · Anesthesiology device
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Feb 1986
Decision
88d
Days
Class 2
Risk

K854571 is an FDA 510(k) clearance for the DEMAND FLOW VALVE & SONRA W/NASAL MASK. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Gale E. Dryden (Indianapolis, US). The FDA issued a Cleared decision on February 10, 1986 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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.

FDA 510(k) Submission Details - K854571

510(k) Number K854571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1985
Decision Date February 10, 1986
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 - CBN Apparatus, Gas-scavenging

All 30
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K854571.
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
K896510 · Technical Medical Products, Inc. · Jan 1990
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · Medipart Jerry Alexander · Aug 1989
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986
GAS EVACUATION ACCESSORY
K852772 · Siemens Elema AB · Oct 1985
OHIO WASTE GAS SCAVENGING RESERVOIR
K841733 · Ohio Medical Products · Jul 1984
OHIO WASTE GAS SCAVENGING INTERFACE
K842003 · Ohio Medical Products · May 1984
K854571 · DEMAND FLOW VALVE & SONRA W/NASAL MASK
Download PDF Gale E. Dryden