# K920379: Novametrix Model 7100 Comb. End Tidal CO2 & Pul OX

- Pathway: 510(k) (Traditional)
- Applicant: Novametrix Medical Systems, Inc.
- Decided: Jul 15, 1992 after 168 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
58 later devices descend from it; 1 cites it directly.
1 of 59 devices in its family (counting itself) has 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.

## 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
- K113623: Patient Monitor (2012), 15 descendants of its own
- K042601: Capnostat 5 (2004), 15 descendants of its own

## Recalls of this device
- Nov 19, 2009 · Not classified · Z-1269-2010: 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-1268-2010: 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-1287-2010: 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/K920379
Methodology: https://510kreport.com/methodology