# K101532: Nessi Otc Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacaribe
- Decided: Sep 1, 2010 after 90 days
- Product code: NVO (Spacer, 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
Longest line of descent: 2 generations back to K010680 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091862: Nessi Spacer, Pharmacaribe (2009) Summary page 4.
- (no number) Primatene Mist – OTC MDI: named in the summary without a submission number

## Indications for use
The NESSI OTC Spacer is intended to be used to administer aerosolized medication from pressurized Metered-Dose Inhalers, which are over-the-counter (OTC), e.g., bronchodilator / epinephrine.

Source page: https://510kreport.com/device/K101532
Methodology: https://510kreport.com/methodology