510(k) · Cleared

Cleared

Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103, S200A-090101 and 300101

K061931510(k) TraditionalCleared Jan 31, 2007208-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Solaris Medical Technology, Inc. · DQA Oximeter

Cleared on Jan 31, 2007 as substantially equivalent to K993637 (Nellcor Puritan Bennett, Inc., 1999) and 2 other predicates after a 208-day review. Its family tree reaches back 4 generations to 1997. 1 of the 14 devices in its family, counting itself, has a Class I recall.

Decided: Jan 31, 2007
Review: 208 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K962603 (1997). 13 ancestors in all, the oldest K873856 (1987). No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
2 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
1 generation backK993637 N-395 Pulse Oximeter, with Extended Device ClaimsNellcor Puritan Bennett, Inc. · 1999 · Recalled
This deviceK061931 Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models…Solaris Medical Technology, Inc. · 2007

Class I recalls in this family

K970209 Capnocheck Plus2 generations back · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−3	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−2	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
−1	K993637	N-395 Pulse Oximeter, with Extended Device Claims	Nellcor Puritan Bennett, Inc.	1999	1
0 (this device)	K061931	Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and…	Solaris Medical Technology, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1996	2	0
1997	2	1
1998	1	0
2001	2	0
2003	1	0

FIG. 1 — Lineage of K061931, 1997–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQA device

#1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K993637	N-395 Pulse Oximeter, with Extended Device Claims Summary page 2 …te Equivalent Devices: Number Manufacturer/Model S100A-090103 SpO2 K993637* Nellcor DS-100A SPO2 Finger Sensor Senso…	Nellcor Puritan Bennett, Inc.	1999	1
*	K030407	Advisor, Model 9200 Summary page 2 …2 Finger Sensor Sensor, 3.0 m cable S200A-090101 SPO2 K030407* BCI 3044 SpO2 Sensor, Finger Sensor 0.9 m…	Bci, Inc.	2003	43
*	K962127	Ohmeda 3800 Pulse Oximeter Summary page 2 …2 Sensor, Finger Sensor 3.0 m cable S300A-300046 SPO2 K962127* Datex-Ohmeda OXY- Finger Sensor F4-H SPO2…	Ohmeda Medical	1996	—

Also cleared against K993637: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K970209Capnocheck PlusBci Intl., Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
7 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
11 other devices also cite its predicate K993637.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · DQA

15in 2025

2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	122	6	325
2008	22	97	5	312
2009	35	117	29	281
2010	29	127	4	185
2011	15	195	1	164
2012	14	120	0	322
2013	15	182	0	468
2014	11	175	2	1,124
2015	13	158	1	2,082
2016	14	246	0	1,775
2017	9	200	0	1,190
2018	18	260	32	694
2019	19	158	0	548
2020	15	126	0	426
2021	10	174	0	553
2022	20	265	0	478
2023	13	317	0	392
2024	14	285	3	545
2025	15	182	0	399
2026	8	187	0	—

What is it indicated for?

Solaris Medical Technology, Inc. SpO2 sensors are indicated for use in continuous, non-invasive monitoring of arterial oxygen saturation and pulse rate for patients weighing more than 40 kg.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061931 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061931: Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103, S200A-090101 and 300101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061931

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026