# K843223: Flow Controller

- Pathway: 510(k) (Traditional)
- Applicant: Precision Medical, Inc.
- Decided: Sep 27, 1984 after 42 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 5, 2010 · Not classified · Z-1561-2010: The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off"

Source page: https://510kreport.com/device/K843223
Methodology: https://510kreport.com/methodology