# K980714: Bci 3401 Handheld Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Mar 25, 1998 after 29 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.
74 later devices descend from it; 3 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BCI 3301 Handheld Pulse Oximeter: named in the summary without a submission number

## Most influential descendants
- K013171: 3420 Digit Pulse Oximeter, Model 3420 (2002), 43 descendants of its own
- K043528: Spirotel (2005), 42 descendants of its own
- K061712: Spirobank II (2006), 40 descendants of its own
- K072979: Spirobank G (2007), 33 descendants of its own
- K991410: 3402 Handheld Pulse Oximeter (1999), 28 descendants of its own

## Indications for use
The BCI 3401 Pulse Oximeter is a handheld, low cost monitor for spot checking or attended monitoring of SpO,, pulse rate and pulse strength. The 3401 is a battery powered pulse oximeter with an optional built-in printer. It may be used in the hospital or clinical environment, and during emergency land. The oximeter will operate accurately over an ambient temperature range of 32 to 131°F (0 to 55°C). The oximeter works with all BCI oximetry sensors providing SpO2 and pulse rate on all patients from neonate to adult. This device is not intended for continuous patient monitoring. There are no audible or visable patient alarms. The device is not intended for home use.

Source page: https://510kreport.com/device/K980714
Methodology: https://510kreport.com/methodology