# K021246: Sensaid, Models# RC-NVA30-10; RC-CS140-10; RC-BC150-3

- Pathway: 510(k) (Special)
- Applicant: Sensidyne, Inc.
- Decided: May 13, 2002 after 24 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
Longest line of descent: 1 generation back to K011974 (2002). 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)
- K011974: Sensaid, Sensidyne, Inc. (2002) Summary page 1.

## Indications for use
Non-invasive monitoring of patient oxygen saturation (SpO3), pulse rate, and plethysmographic pulse wave. The SensAid sensors can be used for Adult, Pediatric and/or Neonate/Infant applications with the appropriate Disposable Positioning Tape (DPT) accessory.

Source page: https://510kreport.com/device/K021246
Methodology: https://510kreport.com/methodology