# K013319: Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Jan 3, 2002 after 90 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: 4 generations back to K910772 (1991). 11 ancestors in all.
124 later devices descend from it; 2 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970763: Modular Telemetry System (MTS) Option for the Mde Escort II Monitor, Medical Data Electronics (1997) Summary page 1.
- K982776: 9303 Neonatal/Adult Vital Signs Monitor, Cas Medical Systems, Inc. (1998) Summary page 1.
- K003004: Oscar 2, Model 222, Suntech Medical Instruments, Inc. (2000) Summary page 1.

## Most influential descendants
- K041156: Avant Digital Pulse Oximetry System, Models 4000, 4001 (2004), 89 descendants of its own
- K043359: 4100 Patient Oximeter Module (2005), 75 descendants of its own
- K031487: Model Avant 2120 Pulse Oximeter and Nibp (2004), 42 descendants of its own
- K081285: Finger Pulse Oximeter, Model 9560 (2008), 40 descendants of its own
- K040589: Modification to Avant 9600 Pulse Oximeter (2004), 27 descendants of its own

## Indications for use
The NONIN® Model 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (Sp0,), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients. Its functions may be used separately or simultaneously. The pulse oximeter is intended for noninvasively monitoring the oxygen saturation and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, and subacute environments. It may be used for spot-checking and/or continuous monitoring of patients. The blood pressure monitor is intended for noninvasively monitoring the blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The blood pressure monitor is not intended for use with neonates. It is intended for attended care and may be used for spot-checking. The Model 2120 should be used for patients with arm circumferences of 18-42 cm.

Source page: https://510kreport.com/device/K013319
Methodology: https://510kreport.com/methodology