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Nebulizer Compressor: Specs and FDA Classification

What the compressor does in a nebulizer system, how FDA classifies it, and how to read pressure, flow, power and filter fields on a spec sheet.

Written and maintained by CASRAI Editorial Board

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This page describes products and general use; it is not medical advice.

A nebulizer compressor is the electric air pump in a compressor-driven nebulizer system. It is for clinic staff, procurement readers and students who need to tell the compressor apart from the cup, tubing and mask, and to read the pressure, flow and power fields on a specification sheet.

What a nebulizer compressor is

The compressor is the air source of a compressor-driven nebulizer. A catalogue entry from the International Federation of Red Cross and Red Crescent Societies (IFRC) describes one such product as “a portable nebuliser operated by an electric compressor pump.” The nebulizer itself is the part that turns liquid into aerosol. For the nebulizer types and what each does, see what a nebulizer is.

Parts and how a compressor system is put together

The same IFRC listing shows how the pieces divide. The compressor unit has a diaphragm inlet with a filter. The set that goes with it holds the nebuliser, tubing, adult and paediatric masks and a mouthpiece, with spare parts. The filter and the fuse are listed as separate item codes, so they are replaceable parts of the compressor rather than part of the nebuliser set.

How regulators identify it

In the United States a nebulizer is defined in 21 CFR 868.5630 as “a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing.” The regulation classifies the device type as Class II (performance standards).

Item What the record says Source
Regulation 21 CFR 868.5630, nebulizer; Class II (performance standards) Cornell LII copy of the CFR, checked 2026-10-30
Example 510(k) K032170, “TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000”, Medical Industries America, Inc.; decision date 05/28/2004; regulation number 868.5630 FDA 510(k) database, checked 2026-10-30
Product code CAF, as shown on the same FDA 510(k) record FDA 510(k) database, checked 2026-10-30

The example shows that a compressor sold together with a nebulizer has been listed in the FDA database under the nebulizer regulation. For how 510(k) clearance works in general, see the FDA 510(k) premarket notification guide, and for how device classes are assigned, FDA medical device classification.

Specification fields, read from one worked example

The IFRC listing for a portable 230 V compressor-nebuliser system gives these values. They describe that one product as listed in the catalogue, whose page is marked as no longer updated (last updated 2018-12-31); they are not typical values for all compressors.

Field Value as listed What the field tells you
Dynamic pressure and flow 6 litres/minute at 0.8 bar Air the compressor delivers, quoted together with the pressure at which it was measured
Power 200 VA, 230 V, 50 Hz Electrical supply the unit needs
Inlet filter Porous polyethylene, 250 micron Filter on the compressor’s diaphragm air inlet
Particle output 80% of drug particles under 5 microns; MMAD 0.5 to 4 micron A figure for the nebuliser set’s aerosol, not for the compressor alone
Chamber capacity 10 ml Nebuliser cup volume
Cited standard EN 13544-1:2001, Respiratory therapy equipment, part 1: nebulising systems and their components; EU class IIa (MDD 93/42/EEC) Standard and class the listing names

Read flow and pressure as a pair: a flow figure means little without the pressure it was measured at. Output figures such as particle size belong to the nebuliser set, so check them against the set that will actually be used.

Where it is used

The IFRC listing places this type of system in hospital use. For another device that supplies a gas stream to a patient circuit, see what an oxygen concentrator is.

Frequently asked questions

What is a nebulizer compressor?

It is the electric air pump of a compressor-driven nebulizer system. The IFRC catalogue describes a product of this kind as “A portable nebuliser operated by an electric compressor pump.”

Is a nebulizer compressor an FDA-regulated device?

The nebulizer device type is classified under 21 CFR 868.5630 as Class II (performance standards). FDA 510(k) record K032170 lists a compressor sold with a nebulizer under that regulation number.

What does a flow figure such as 6 litres/minute at 0.8 bar mean?

It pairs the air flow with the pressure at which it was measured. The figure is from one catalogue example and is not a typical value for all compressors.

Are particle-size figures a property of the compressor?

No. In the IFRC listing, the particle output figures describe the nebuliser set’s aerosol, so they belong to the set rather than the compressor alone.

Sources

Dates are the day each source was last checked.

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