# K021742: Galemed Neb-Easy Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Galemed Corp.
- Decided: Oct 25, 2002 after 150 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K883968: Tenderfoot, International Technidyne Corp. (1988). Our reading of the summary gave K883968, FDA’s number for Tenderfoot (International Technidyne Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Allegiance Misty-Neb Nebulizer”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K031908: MED2000 Spa Nebulizer Compressors, Models P1 and P2, with Nebulizer, and MED2000 Spa Nebulizer, Model A1/C (Andyflow) (2004), 4 descendants of its own
- K051365: Compressor Nebulizer System, Model KN-9321 (2005), 1 descendant of its own
- K083256: Ultrasonic Nebulizer System, Model KN-9210 (2009), 0 descendants of its own
- K053490: Merits Health Products Portable Nebulizer (2006), 0 descendants of its own
- K041974: MED2000 Nebulizer Compressor, Models P3, P4, P5 with Nebulizer (2004), 0 descendants of its own

## Indications for use
The GaleMed Neb-Easy Nebulizer is a pneumatic nebulizer which nebulizes specific drugs for inhalation by a patient. It is for adult and pediatric patients.

Source page: https://510kreport.com/device/K021742
Methodology: https://510kreport.com/methodology