510(k) Report

510(k) · Cleared

Cleared

AS/3 Light Monitor

K961247510(k) TraditionalCleared Oct 23, 1996205-day reviewClass II21 CFR 870.2340

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

Datex Division Instrumentarium Corp. · DPS Electrocardiograph

Cleared on Oct 23, 1996 after a 205-day review. The FDA summary names its predicate without a number. 511 later devices descend from it.

Decided
Oct 23, 1996
Review
205 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 5 descendants cleared2004: 12 descendants cleared2007: 9 descendants cleared2012: 22 descendants cleared2005: 13 descendants cleared2006: 18 descendants cleared2009: 20 descendants cleared2011: 30 descendants cleared2010: 28 descendants cleared2013: 20 descendants cleared2008: 18 descendants cleared2015: 19 descendants cleared2002: 7 descendants cleared2000: 1 descendant cleared2001: 2 descendants cleared2003: 5 descendants cleared2016: 21 descendants cleared2017: 22 descendants cleared2018: 27 descendants cleared2014: 22 descendants cleared2021: 21 descendants cleared2022: 28 descendants cleared2020: 18 descendants cleared2023: 27 descendants cleared2019: 18 descendants cleared2025: 29 descendants cleared2026: 22 descendants cleared2024: 27 descendants cleared1995200020052010201520202025
  1. This deviceK961247 AS/3 Light MonitorDatex Division Instrumentarium Corp. · 1996
  2. Descendant · cites it directly · 510 of its ownK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  3. Descendant · 2 generations on · 509 of its ownK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  4. Descendant · 3 generations on · 462 of its ownK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  5. Descendant · 3 generations on · 451 of its ownK992273 HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000
  6. Descendant · 3 generations on · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001

Showing 5 of 511 descendants. See all descendants

Descendants cleared per year

1999: 52000: 12001: 22002: 72003: 52004: 122005: 132006: 182007: 92008: 182009: 202010: 282011: 302012: 222013: 202014: 222015: 192016: 212017: 222018: 272019: 182020: 182021: 212022: 282023: 272024: 272025: 292026: 22
1999high 30 (2011) · low 1 (2000)2026

Most influential descendants

Showing 5 of 511 · See all
  • K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999 · cites it directly510descendants
  • K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999 · 2 generations on509descendants
  • K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH · 1999 · 3 generations on462descendants
  • K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH · 2000 · 3 generations on451descendants
  • K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · 3 generations on431descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961247AS/3 Light MonitorDatex Division Instrumentarium Corp.1996—
+1K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
+2K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
+3K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
+3K992273HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Hewlett-Packard GmbH2000—
+3K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199950
200010
200120
200270
200350
2004120
2005130
2006180
200790
2008180
2009200
2010280
2011300
2012220
2013200
2014220
2015190
2016210
2017220
2018270
2019180
2020180
2021210
2022280
2023270
2024270
2025290
2026220
FIG. 1 — Lineage of K961247, 1996–2026Source: 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 DPS? 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 DPS device

  1. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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? (1)

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
*—Datex AS/3 Compact Monitor with ESTP and NIBP modules
Named without a submission number
—

What descends from it? (511)

See all 511

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

NumberDeviceApplicantDecidedDescendants
K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999510

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, K981376 (Hewlett-Packard Co., 1999) has gone furthest, with 510 descendants of its own.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, 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
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

What is it indicated for?

AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient’s vital signs.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Datex Division Instrumentarium Corp.

55 FDA decisions under this applicant name. See the company

  • K953175AS/3 Estpr ModuleDatex Division Instrumentarium Corp. · 1997
  • K943458AS/3 Airway ModuleDatex Division Instrumentarium Corp. · 1995
  • K945234AS/3 Memory Module, M0MEMDatex Division Instrumentarium Corp. · 1995
  • K933156Datex as/3 Patient MonitorDatex Division Instrumentarium Corp. · 1994
  • K933285Datex as/3 TM Anaesthesia MonitorDatex Division Instrumentarium Corp. · 1994

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https://510kreport.com/device/K961247 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961247: AS/3 Light Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961247

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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