# K032971: Tidal Wave SP Model 710/715                                       and 715

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Novametrix, Inc.
- Decided: Aug 26, 2004 after 339 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920379 (1992). 3 ancestors in all.
57 later devices descend from it; 4 cite it directly.
1 of 61 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963327: Tidal Wave Carbon Dioxide Monitor, Model 610, Novametrix Medical Systems, Inc. (1996) Summary page 1.
- K920379: Novametrix Model 7100 Comb. End Tidal CO2 & Pul OX, Novametrix Medical Systems, Inc. (1992) Summary page 1.
- K924626: Novametrix Model 510, Novametrix Medical Systems, Inc. (1993) Summary page 1.

## Most influential descendants
- K083821: Vital Signs Monitor (2009), 39 descendants of its own
- K093016: Vital Signs Monitor (2010), 16 descendants of its own
- K113623: Patient Monitor (2012), 15 descendants of its own
- K042601: Capnostat 5 (2004), 15 descendants of its own
- K131971: IM60/IM70 Patient Monitor (2014), 14 descendants of its own

## Recalls of this device
- Nov 19, 2009 · Not classified · Z-1279-2010: 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-1278-2010: 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-1292-2010: 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-1276-2010: 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-1290-2010: 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-1277-2010: 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-1263-2010: 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

## Indications for use
The intended use of the TidalWave Sp (Models 710/715) is to provide short term monitoring of carbon dioxide and oxygen saturation during anesthesia / recovery, in the intensive care unit (ICU). and in Emergency Medicine/Transport or Respiratory care. Separate airway adapters are provided for pediatric/adult and neonatal/pediatric use.

Source page: https://510kreport.com/device/K032971
Methodology: https://510kreport.com/methodology