# K001688: Datex-Ohmeda Tuffsat 3000 Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Jun 30, 2000 after 28 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.
17 later devices descend from it; 2 cite it directly.
0 of 18 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
- K052693: PM-50 Pulse Oximeter (2006), 13 descendants of its own
- K061442: Pulse Oximeter, Model PM-50 (2006), 8 descendants of its own
- K072235: PM-50 Pulse Oximeter and VS-800 Vital Signs Monitor (2007), 7 descendants of its own
- K172792: Handheld Pulse Oximeter, Model SP-20 (2018), 3 descendants of its own
- K132037: Vital Signs Monitor (2014), 3 descendants of its own

Source page: https://510kreport.com/device/K001688
Methodology: https://510kreport.com/methodology