510(k) Report

510(k) · Cleared

Cleared

Comsat Adult,Pediatric,Infant,Neonatal Disposable Sensor and Comsat Reusable Finger Sensor

K960251510(k) TraditionalCleared Mar 26, 199668-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

Aristo Medical Products, Inc. · DQA Oximeter

Cleared on Mar 26, 1996 after a 68-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.

Decided
Mar 26, 1996
Review
68 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2004: 1 descendant cleared2003: 2 descendants cleared2006: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960251 Comsat Adult,Pediatric,Infant,Neonatal Disposable Sensor and Comsat…Aristo Medical Products, Inc. · 1996
  2. Descendant · cites it directly · 4 of its ownK012989 Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070Dolphin Medical, Inc. · 2002
  3. Descendant · 2 generations on · 3 of its ownK030952 Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312…Dolphin Medical, Inc. · 2003
  4. Descendant · 3 generations on · 1 of its ownK032947 Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc. · 2003
  5. Descendant · 2 generations on · 0 of its ownK060524 Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable…Dolphin Medical, Inc. · 2006
  6. Descendant · 2 generations on · 0 of its ownK033876 Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321…Dolphin Medical, Inc. · 2004

Most influential descendants

Showing 5 of 5 · See all
  • K012989Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070Dolphin Medical, Inc. · 2002 · cites it directly4descendants
  • K030952Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric, 2313…Dolphin Medical, Inc. · 2003 · 2 generations on3descendants
  • K032947Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc. · 2003 · 3 generations on1descendant
  • K060524Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and Extension…Dolphin Medical, Inc. · 2006 · 2 generations on0descendants
  • K033876Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342…Dolphin Medical, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960251Comsat Adult,Pediatric,Infant,Neonatal Disposable Sensor and Comsat Reusable…Aristo Medical Products, Inc.1996—
+1K012989Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070Dolphin Medical, Inc.2002—
+2K030952Dolphin 2000 Pulse Oximetry Sensors Models 2010, 2311 Adult, 2312 Pediatric…Dolphin Medical, Inc.2003—
+3K032947Nellcor Compatible Dolphin 2000 Y Oximetry Sensor, Model 2210Dolphin Medical, Inc.2003—
+2K060524Dolphin 2000 Datex Compatible Oximetry Disposable and Reusable Sensors and…Dolphin Medical, Inc.2006—
+2K033876Dolphin 2000 Oximetry Sensors, Models 2020, 2040, 2060, 2070, 2321, 2323…Dolphin Medical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200410
200610
FIG. 1 — Lineage of K960251, 1996–2006Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K012989Dolphin 2000 Oximetry Sensor, Models, 2050, 2351, 2354, 2070Dolphin Medical, Inc.20024

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, K012989 (Dolphin Medical, Inc., 2002) has gone furthest, with 4 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—

More from Aristo Medical Products, Inc.

4 FDA decisions under this applicant name. See the company

  • K961060Aristo Esophageal StethoscopeAristo Medical Products, Inc. · 1996
  • K953817Aristo Medical Model 2101 Patient MonitorAristo Medical Products, Inc. · 1995
  • K920966Sdi Oxygen/Digital Oxygen Transducers (Dot)Aristo Medical Products, Inc. · 1993

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/K960251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960251: Comsat Adult,Pediatric,Infant,Neonatal Disposable Sensor and Comsat Reusable Finger Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960251

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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