510(k) Report

510(k) · Cleared

Cleared

Tenacore SP02 Sensors

K053420510(k) TraditionalCleared Nov 15, 2006342-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

Tenacore Holdings, Inc. · DQA Oximeter

Cleared on Nov 15, 2006 as substantially equivalent to K973970 (Medical Cables, Inc., 1998) and 1 other predicate after a 342-day review. Its family tree reaches back 1 generation to 1998. 16 later devices descend from it.

Decided
Nov 15, 2006
Review
342 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K973970 (1998). 2 ancestors in all. 16 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2008: 1 descendant cleared2015: 1 descendant cleared2020: 3 descendants cleared2019: 2 descendants cleared2025: 6 descendants cleared2018: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK973970 · SPO2 Finger Probes · Medical Cables, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 10 descendants4 generations forward: 3 descendants K973970 · SPO2 Finger Probes · Medical Cables, Inc. · 19980
  1. Root · 1 generation backK973970 SPO2 Finger ProbesMedical Cables, Inc. · 1998
  2. This deviceK053420 Tenacore SP02 SensorsTenacore Holdings, Inc. · 2006
  3. Descendant · cites it directly · 15 of its ownK082546 Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger…Unimed Medical Supplies, Inc. · 2008
  4. Descendant · 2 generations on · 14 of its ownK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
  5. Descendant · 3 generations on · 1 of its ownK242580 Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable…Unimed Medical Supplies, Inc. · 2025
  6. Descendant · 2 generations on · 1 of its ownK202851 Spo2 SensorJkh USA, LLC · 2020
  7. Descendant · 3 generations on · 1 of its ownK201360 Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd. · 2020

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2008: 12015: 12018: 12019: 22020: 32024: 12025: 62026: 1
2008high 6 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 16 · See all
  • K082546Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips…Unimed Medical Supplies, Inc. · 2008 · cites it directly15descendants
  • K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015 · 2 generations on14descendants
  • K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc. · 2025 · 3 generations on1descendant
  • K202851Spo2 SensorJkh USA, LLC · 2020 · 2 generations on1descendant
  • K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd. · 2020 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K973970SPO2 Finger ProbesMedical Cables, Inc.1998—
0 (this device)K053420Tenacore SP02 SensorsTenacore Holdings, Inc.2006—
+1K082546Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip…Unimed Medical Supplies, Inc.2008—
+2K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.2015—
+3K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger…Unimed Medical Supplies, Inc.2025—
+2K202851Spo2 SensorJkh USA, LLC2020—
+3K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201510
201810
201920
202030
202410
202560
202610
FIG. 1 — Lineage of K053420, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K973970SPO2 Finger Probes
Summary page 1
…so, QA Director Ph: 714-444-4643 Fx: 714-549-7835 Date Prepared November 1,2005 Product Name SpO2 Sensor (accessory to pulse oximeter) Predicate Device K973970, K002223 Product Description SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact…
Medical Cables, Inc.1998—
*K002223Epic SPO2 Finger Sensor, Model E412-20
Summary page 1
…rector Ph: 714-444-4643 Fx: 714-549-7835 Date Prepared November 1,2005 Product Name SpO2 Sensor (accessory to pulse oximeter) Predicate Device K973970, K002223 Product Description SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat…
Epic Medical Equipment Services, Inc.2000—

What descends from it? (16)

See all 16

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082546Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips…Unimed Medical Supplies, Inc.200815

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K082546 (Unimed Medical Supplies, Inc., 2008) has gone furthest, with 15 descendants of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
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

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

Accessory to pulse oximeter for the purpose of continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.

Indications for use as stated in the FDA summary.

More from Tenacore Holdings, Inc.

4 FDA decisions under this applicant name. See the company

  • K081335Tenacore Oxygen Blender, Model TB-2000Tenacore Holdings, Inc. · 2008
  • K043075Tenacore Transducers for Fetal Ultrasonic and Tokodynamometer MonitoringTenacore Holdings, Inc. · 2005
  • K012041The Hammer Model H100Tenacore Holdings, Inc. · 2002

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K053420 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053420: Tenacore SP02 Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053420

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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