# K001085: Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500

- Pathway: 510(k) (Special)
- Applicant: Nonin Medical, Inc.
- Decided: May 1, 2000 after 27 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.
197 later devices descend from it; 4 cite it directly.
0 of 198 devices in its family (counting itself) have 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
- K051107: Onyx II Finger Pulse Oximeter, Model 9550 (2005), 154 descendants of its own
- K070371: Fingertip Pulse Oximeter MD300C (2007), 79 descendants of its own
- K053130: Onyx II Finger Pulse Oximeter, Model 9550 (2006), 59 descendants of its own
- K013171: 3420 Digit Pulse Oximeter, Model 3420 (2002), 43 descendants of its own
- K043528: Spirotel (2005), 42 descendants of its own

Source page: https://510kreport.com/device/K001085
Methodology: https://510kreport.com/methodology