# K973347: TSX PRM Pulmonary Resuscitation Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Spiracle Technology
- Decided: Jul 23, 1998 after 321 days
- Product code: CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm))
- Device class: 2
- Regulation: 21 CFR 868.2600
- 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 K812140 (1981). 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)
- K812140: Bird Mean Airway Pressure Monitor, 3M Company (1981) Summary page 1.

## Cited in the summary but kept off the family tree
- K814608: Sechrist Industries, Inc., Airway Pressure Monitor Model 400. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The TDx PRM is intended to be used as an accessory to emergency resuscitators and ventilators to monitor ventilatory functions including peak inspiratory pressure, respiratory rate, positive end expiratory pressure, and inspiratory/expiratory time ratio.

Source page: https://510kreport.com/device/K973347
Methodology: https://510kreport.com/methodology