510(k) Report

510(k) · Cleared

Cleared

Smartsat Pulse Oximetry Analyzer

K952327510(k) TraditionalCleared Aug 25, 199599-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

Clinical Dynamics Corp. · DQA Oximeter

Cleared on Aug 25, 1995 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.

Decided
Aug 25, 1995
Review
99 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

23 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1999: 1 descendant cleared2004: 1 descendant cleared2003: 1 descendant cleared2002: 2 descendants cleared2006: 1 descendant cleared2021: 1 descendant cleared2018: 2 descendants cleared2017: 3 descendants cleared2008: 1 descendant cleared2009: 2 descendants cleared2013: 2 descendants cleared2010: 1 descendant cleared2023: 1 descendant cleared2015: 2 descendants cleared2016: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952327 Smartsat Pulse Oximetry AnalyzerClinical Dynamics Corp. · 1995
  2. Descendant · cites it directly · 22 of its ownK971273 Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F…Bio-Tek Instruments, Inc. · 1997
  3. Descendant · 2 generations on · 21 of its ownK992340 Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop…Masimo Corp. · 1999 · Recalled
  4. Descendant · 3 generations on · 11 of its ownK062144 Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006
  5. Descendant · 4 generations on · 10 of its ownK090556 Spacelabs Elance Vital Signs Monitoring System and Central Monitor…Spacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · Recalled
  6. Descendant · 3 generations on · 5 of its ownK040178 Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12002: 22003: 12004: 12006: 12008: 12009: 22010: 12013: 22015: 22016: 12017: 32018: 22021: 12023: 1
1997high 3 (2017) · low 0 (1998)2026

Most influential descendants

Showing 5 of 23 · See all
  • K971273Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFBio-Tek Instruments, Inc. · 1997 · cites it directly22descendants
  • K992340Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999 · 2 generations on21descendants
  • K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006 · 3 generations on11descendants
  • K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · 4 generations on10descendants
  • K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952327Smartsat Pulse Oximetry AnalyzerClinical Dynamics Corp.1995—
+1K971273Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFBio-Tek Instruments, Inc.1997—
+2K992340Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop…Masimo Corp.19991
+3K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation2006—
+4K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO20091
+3K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200220
200310
200410
200610
200810
200920
201010
201320
201520
201610
201730
201820
202110
202310
FIG. 1 — Lineage of K952327, 1995–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K971273Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFBio-Tek Instruments, Inc.199722

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?

  • Of its descendants, K971273 (Bio-Tek Instruments, Inc., 1997) has gone furthest, with 22 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—

Recent decisions in DQA

The DQA category page

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https://510kreport.com/device/K952327 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952327: Smartsat Pulse Oximetry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952327

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026