Cleared Traditional

K870027 - HAND HELD PHEUMATIC POWERED (DISPOSABLE...

K870027 is an FDA 510(k) clearance for HAND HELD PHEUMATIC POWERED (DISPOSABLE..., manufactured by Salter Labs. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K870027 · Salter Labs · Anesthesiology device
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Mar 1987
Decision
70d
Days
Class 1
Risk

K870027 is an FDA 510(k) clearance for the HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - 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 - K870027

510(k) Number K870027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1987
Decision Date March 16, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 140d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

CCQ Device Classification - Class 1, General Controls

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)

All 18
Devices cleared under the same product code (CCQ) and FDA review panel - the closest regulatory comparables to K870027.
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CHALLENGER DOSIMETER
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