510(k) Report

510(k) · Cleared

Cleared

Datex as/3 Patient Monitor

K933156510(k) TraditionalCleared Dec 30, 1994549-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 Dec 30, 1994 after a 549-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.

Decided
Dec 30, 1994
Review
549 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
0

12 later devices descend from it, 1 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2004: 1 descendant cleared, 1 with a Class I recall12012: 1 descendant cleared2013: 2 descendants cleared2014: 1 descendant cleared, 1 with a Class I recall12015: 2 descendants cleared2020: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK933156 Datex as/3 Patient MonitorDatex Division Instrumentarium Corp. · 1994
  2. Descendant · cites it directly · 11 of its ownK043276 Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and…Datex-Ohmeda · 2004 · Recalled (Class I)
  3. Descendant · 2 generations on · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled
  4. Descendant · 3 generations on · 8 of its ownK130584 Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · Recalled
  5. Descendant · 4 generations on · 7 of its ownK133576 Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · Recalled (Class I)
  6. Descendant · 5 generations on · 5 of its ownK151063 Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2004: 12012: 12013: 22014: 12015: 22017: 12020: 12022: 12024: 12025: 1
2004high 2 (2013) · low 0 (2005)2026

Class I recalls in this family

  • K043276 Datex-Ohmeda S/5TM FM with L-FICU04 and…cites it directly · 2004
  • K133576 Monitor B404 generations on · 2014

Most influential descendants

Showing 5 of 12 · See all
  • K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda · 2004 · cites it directly11descendants
  • K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · 2 generations on10descendants
  • K130584Monitor B40Ge Medical Systems China Co., Ltd. · 2013 · 3 generations on8descendants
  • K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on7descendants
  • K151063Monitor B40Ge Medical Systems China Co., Ltd. · 2015 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933156Datex as/3 Patient MonitorDatex Division Instrumentarium Corp.1994—
+1K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda2004Class I
+2K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.20122
+3K130584Monitor B40Ge Medical Systems China Co., Ltd.20132
+4K133576Monitor B40Ge Medical Systems China Co., Ltd.2014Class I
+5K151063Monitor B40Ge Medical Systems China Co., Ltd.20151

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200411
201210
201320
201411
201520
201710
202010
202210
202410
202510
FIG. 1 — Lineage of K933156, 1994–2025Source: 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.

2 devices in this family have a Class I recall. 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?

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

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module Class IDatex-Ohmeda200411

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
  • K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K043276 (Datex-Ohmeda, 2004) has gone furthest, with 11 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—

More from Datex Division Instrumentarium Corp.

55 FDA decisions under this applicant name. See the company

  • K953175AS/3 Estpr ModuleDatex Division Instrumentarium Corp. · 1997
  • K961247AS/3 Light MonitorDatex Division Instrumentarium Corp. · 1996
  • K943458AS/3 Airway ModuleDatex Division Instrumentarium Corp. · 1995
  • K945234AS/3 Memory Module, M0MEMDatex Division Instrumentarium Corp. · 1995
  • K933285Datex as/3 TM Anaesthesia MonitorDatex Division Instrumentarium Corp. · 1994

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https://510kreport.com/device/K933156 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933156: Datex as/3 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933156

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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