# K963327: Tidal Wave Carbon Dioxide Monitor, Model 610

- Pathway: 510(k) (Traditional)
- Applicant: Novametrix Medical Systems, Inc.
- Decided: Nov 20, 1996 after 89 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
75 later devices descend from it; 4 cite it directly.
4 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K032971: Tidal Wave SP Model 710/715                                       and 715 (2004), 57 descendants of its own
- K083821: Vital Signs Monitor (2009), 39 descendants of its own
- K093016: Vital Signs Monitor (2010), 16 descendants of its own
- K051857: Veo Multigas Monitor for Pocket PC, Model 400221 (2005), 16 descendants of its own
- K113623: Patient Monitor (2012), 15 descendants of its own

## Recalls of this device
- Nov 19, 2009 · Not classified · Z-1289-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1294-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1283-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti
- Nov 19, 2009 · Not classified · Z-1273-2010: Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defecti

Source page: https://510kreport.com/device/K963327
Methodology: https://510kreport.com/methodology