# K953817: Aristo Medical Model 2101 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Aristo Medical Products, Inc.
- Decided: Nov 22, 1995 after 100 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K030629: Dolphin Medical 2150 Handheld Pulse Oximeter (2003), 2 descendants of its own
- K040380: Dolphin Medical Dolphin One Adult Reusable Forehead Sensor, Model 420 (2004), 1 descendant of its own
- K242290: DormoTech NLab (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K953817
Methodology: https://510kreport.com/methodology