# K051212: Modification to LNCS Oximetry Sensors

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Jul 12, 2005 after 62 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K941811 (1994). 65 ancestors in all.
85 later devices descend from it; 12 cite it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041815: LNCS Oximetry Sensors, Masimo Corp. (2004) Summary page 1.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 1.
- (no number) SPO2.COM A, P, I, N, RS-I Pulse Oximeter Sensors: named in the summary without a submission number

## Most influential descendants
- K101896: Masimo LNCS/M-LNCS Oximetry Sensors (2010), 62 descendants of its own
- K111888: Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors (2011), 59 descendants of its own
- K100617: Masimo Responsable Oximetry Sensors Model S2-25/25D; S2-20/20D (2010), 39 descendants of its own
- K111621: Masimo Resposable SPO2 Series Oximetry Sensors, Masimo LNCS / M-LNCS Oximetry Sensors (2011), 38 descendants of its own
- K120657: Masimo Set and Masimo Rainbow Set Pulse Oximeters and Sensors (2012), 37 descendants of its own

## Recalls of this device
- Apr 21, 2023 · Class II · Z-1986-2023: TC-I tip clip sensor may produce readings outside the accuracy specification.
- Apr 21, 2023 · Class II · Z-1985-2023: TC-I tip clip sensor may produce readings outside the accuracy specification.
- Apr 4, 2016 · Class II · Z-2641-2017: Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- Apr 4, 2016 · Class II · Z-2640-2017: Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
- Apr 4, 2016 · Class II · Z-2642-2017: Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.

## Indications for use
The LNCS Sensors are indicated for the continuous noninvasive monitoring of functional-oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K051212
Methodology: https://510kreport.com/methodology