# K893221: Model 8500 Hand Held Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Feb 28, 1990 after 307 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
431 later devices descend from it; 4 cite it directly.
1 of 432 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
- K980879: Oscillomate Nibp / SP02 Ems Monitor (1998), 426 descendants of its own
- K982776: 9303 Neonatal/Adult Vital Signs Monitor (1998), 425 descendants of its own
- K033048: Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS (2004), 272 descendants of its own
- K050844: 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL (2005), 264 descendants of its own
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), 250 descendants of its own

## Recalls of this device
- Sep 29, 2016 · Class II · Z-1690-2017: Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pu

Source page: https://510kreport.com/device/K893221
Methodology: https://510kreport.com/methodology