# K011974: Sensaid

- Pathway: 510(k) (Traditional)
- Applicant: Sensidyne, Inc.
- Decided: Feb 12, 2002 after 232 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K021246: Sensaid, Models# RC-NVA30-10; RC-CS140-10; RC-BC150-3 (2002), 0 descendants of its own

## Indications for use
Non-invasive monitoring of patient oxygen saturation (SpO2), pulse rate, and plethysmographic pulse wave. The SensAid sensors can be used for Adult, Pediatric and/or Neonate/Infant applications with the appropriate DPT accessory.

Source page: https://510kreport.com/device/K011974
Methodology: https://510kreport.com/methodology