Cleared Traditional

K912434 - SALTER LABS INFANT NASAL CPAP CANNULA

K912434 is an FDA 510(k) clearance for SALTER LABS INFANT NASAL CPAP CANNULA, manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K912434 · Salter Labs · Anesthesiology device
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Jul 1991
Decision
57d
Days
Class 2
Risk

K912434 is an FDA 510(k) clearance for the SALTER LABS INFANT NASAL CPAP CANNULA. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on July 30, 1991 after a review of 57 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 Salter Labs devices

FDA 510(k) Submission Details - K912434

510(k) Number K912434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date July 30, 1991
Days to Decision 57 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 140d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
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 - BZD Ventilator, Non-continuous (respirator)

All 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K912434.
REMSTAR WTIH RAMP AND REMOTE MODIFICATION
K920699 · Respironics, Inc. · Dec 1992
INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
K911465 · Vital Signs, Inc. · Oct 1991
RESPIRONICS REMSTAR WITH REMOTE AND RAMP
K911856 · Respironics, Inc. · Aug 1991
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
K911780 · Ackrad Laboratories · Jun 1991
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM
K905404 · Medtronic Vascular · May 1991
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
K910194 · Puritan Bennett Corp. · May 1991