# K181424: PeDIA

- Pathway: 510(k) (Traditional)
- Applicant: Pedia, LLC
- Decided: Sep 25, 2018 after 117 days
- Product code: BTC (Bag, Reservoir)
- Device class: 1
- Regulation: 21 CFR 868.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880680 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880680: King Systems, Breathing Bag, King Systems Corp. (1988) Summary page 4.

## Indications for use
The pediatric device for induction of anesthesia (PeDIA) is an alternative to a face mask for the inhalation induction of anesthesia, and is intended for the delivery of nitrous and/or anesthetic gases to children age three years and older. It is intended to be used prior to IV insertion, LMA/endotracheal intubation, and/or conversion to a standard mask induction

Source page: https://510kreport.com/device/K181424
Methodology: https://510kreport.com/methodology