# K113865: Pultol

- Pathway: 510(k) (Traditional)
- Applicant: Sharp Corporation
- Decided: Mar 21, 2012 after 82 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: 8 generations back to K910772 (1991). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081285: Finger Pulse Oximeter, Model 9560, Nonin Medical, Inc. (2008) Summary page 1.
- K001085: Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500, Nonin Medical, Inc. (2000)
- K053419: Konica Minolta Pulsox-300, 300I, Konica Minolta Sensing, Inc. (2006) Summary page 1.

## Indications for use
The Sharp Pulse Oximeter Model BM-500 and BM-510 is a non-invasive pulse oximeter indicated for use in the spot-check measurement and display of arterial blood oxygen saturation (SpO2) and pulse rate in hospital or primary care settings.

Source page: https://510kreport.com/device/K113865
Methodology: https://510kreport.com/methodology