510(k) · Cleared

Cleared

Mediaid Disposable Non-Adhesive Sensors, Model CST050-2101N; Reusable Finger Clip SP02 Sensors, Model CST060-2101N

K061896510(k) TraditionalCleared Apr 12, 2007283-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

Cleared on Apr 12, 2007 as substantially equivalent to K994372 (Palco Labs, Inc., 2000) and 3 other predicates after a 283-day review. Its family tree reaches back 1 generation to 1991.

Decided: Apr 12, 2007
Review: 283 days
Class: Class II
Product code: DQA
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K911191 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK911191 Palco Labs Model 300 Oxygen/Pulse MonitorPalco Laboratories, Inc. · 1991
This deviceK061896 Mediaid Disposable Non-Adhesive Sensors, Model CST050-2101N…Mediaid, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K911191	Palco Labs Model 300 Oxygen/Pulse Monitor	Palco Laboratories, Inc.	1991	—
0 (this device)	K061896	Mediaid Disposable Non-Adhesive Sensors, Model CST050-2101N; Reusable Finger…	Mediaid, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	3	0

FIG. 1 — Lineage of K061896, 1991–2007Source: 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.

Planning a device in DQA? 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

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What was it cleared against? (4)

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
*	K994372	MODEL 120 Summary page 2 …oximeter) Regulation: 21 CFR 870.2700 Product Code: DQA Class: II Predicate Device: Mediaid (formerly Palco) currently markets its own pulse oximetry system under K994372 and K91 1191. Mediaid wishes to extend its product line to include its own brand of pulse oximeter sensors that are compatibile…	Palco Labs, Inc.	2000	—
*	K911191	Palco Labs Model 300 Oxygen/Pulse Monitor Summary page 2 …Regulation: 21 CFR 870.2700 Product Code: DQA Class: II Predicate Device: Mediaid (formerly Palco) currently markets its own pulse oximetry system under K994372 and K91 1191. Mediaid wishes to extend its product line to include its own brand of pulse oximeter sensors that are compatibile with Nonin p…	Palco Laboratories, Inc.	1991	—
*	K001930	Model 8500, Hand Held Pulse Oximeter, Model 8500 Summary page 2 …end its product line to include its own brand of pulse oximeter sensors that are compatibile with Nonin pulse oximeters. Nonin pulse oximeter sensors are marketed under K001930 and K002690. Description: Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical…	Nonin Medical, Inc.	2000	—
*	K002690	Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500 Summary page 2 …ct line to include its own brand of pulse oximeter sensors that are compatibile with Nonin pulse oximeters. Nonin pulse oximeter sensors are marketed under K001930 and K002690. Description: Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or…	Nonin Medical, Inc.	2000	2

Also cleared against K994372: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 4 ancestors has a recall of any class.
1 other device also cites its predicate K994372.

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?

Mediaid's compatible sensors are indicated as accessories to pulse oximeters used on Pulse Oximeters manufactured by Nonin Inc for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in infant, pediatric, and adult patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061896 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061896: Mediaid Disposable Non-Adhesive Sensors, Model CST050-2101N; Reusable Finger Clip SP02 Sensors, Model CST060-2101N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061896

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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