Cleared Traditional

K860875 - CIRRUS DRUG NEBULIZER MK III

K860875 is an FDA 510(k) clearance for CIRRUS DRUG NEBULIZER MK III, manufactured by Dhd Medical Products Div. Diemolding Corp.. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K860875 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology device
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Mar 1986
Decision
23d
Days
Class 1
Risk

K860875 is an FDA 510(k) clearance for the CIRRUS DRUG NEBULIZER MK III. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on March 20, 1986 after a review of 23 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 Dhd Medical Products Div. Diemolding Corp. devices

FDA 510(k) Submission Details - K860875

510(k) Number K860875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1986
Decision Date March 20, 1986
Days to Decision 23 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
117d faster than avg
Panel avg: 140d · This submission: 23d
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 24
Devices cleared under the same product code (CCQ) and FDA review panel - the closest regulatory comparables to K860875.
PREFILLED RESPIRATORY THERAPY VIALS
K870332 · Automatic Liquid Packaging, Inc. · Apr 1987
HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER
K870027 · Salter Labs · Mar 1987
CHALLENGER DOSIMETER
K870755 · Salter Labs · Mar 1987
CIRRUS NEBULIZER-DELUXE KIT
K854952 · Dhd Medical Products Div. Diemolding Corp. · Jan 1986
MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA
K854550 · Medipart Jerry Alexander · Dec 1985
MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S
K854551 · Medipart Jerry Alexander · Dec 1985