510(k) Report

510(k) · Cleared

Cleared

Datascope Passport Monitor

K911598510(k) TraditionalCleared Oct 15, 1991189-day reviewClass II21 CFR 870.2300

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

Datascope Corp. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cleared on Oct 15, 1991 after a 189-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 270 devices in its family, counting itself, has a Class I recall. 269 later devices descend from it.

Decided
Oct 15, 1991
Review
189 days
Class
Class II
Product code
DRT
Recalls
None
Predicates
0

269 later devices descend from it, 2 citing it directly. 1 of the 270 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1996: 1 descendant cleared1999: 1 descendant cleared2016: 12 descendants cleared2002: 1 descendant cleared2017: 15 descendants cleared2005: 1 descendant cleared2006: 2 descendants cleared2012: 15 descendants cleared2009: 7 descendants cleared2010: 8 descendants cleared2007: 1 descendant cleared2022: 24 descendants cleared2021: 11 descendants cleared2008: 1 descendant cleared2011: 6 descendants cleared2013: 14 descendants cleared2018: 15 descendants cleared2025: 19 descendants cleared2026: 16 descendants cleared2015: 13 descendants cleared2014: 18 descendants cleared, 1 with a Class I recall12019: 16 descendants cleared2020: 16 descendants cleared2023: 16 descendants cleared2024: 20 descendants cleared1990200020102020
  1. This deviceK911598 Datascope Passport MonitorDatascope Corp. · 1991
  2. Descendant · cites it directly · 267 of its ownK984033 Atlas MonitorWelch Allyn, Inc. · 1999
  3. Descendant · 2 generations on · 264 of its ownK022084 Atlas Monitor, Models 200,210,220Welch Allyn, Inc. · 2002
  4. Descendant · 3 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
  5. Descendant · 4 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
  6. Descendant · 5 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled

Showing 5 of 269 descendants. See all descendants

Descendants cleared per year

1996: 11999: 12002: 12005: 12006: 22007: 12008: 12009: 72010: 82011: 62012: 152013: 142014: 182015: 132016: 122017: 152018: 152019: 162020: 162021: 112022: 242023: 162024: 202025: 192026: 16
1996high 24 (2022) · low 0 (1997)2026

Class I recalls in this family

  • K123690 CAPNOSTREAM20P with Hifi C02 Monitoring9 generations on · 2014

Most influential descendants

Showing 5 of 269 · See all
  • K984033Atlas MonitorWelch Allyn, Inc. · 1999 · cites it directly267descendants
  • K022084Atlas Monitor, Models 200,210,220Welch Allyn, Inc. · 2002 · 2 generations on264descendants
  • K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 3 generations on250descendants
  • K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 4 generations on197descendants
  • K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 5 generations on170descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911598Datascope Passport MonitorDatascope Corp.1991—
+1K984033Atlas MonitorWelch Allyn, Inc.1999—
+2K022084Atlas Monitor, Models 200,210,220Welch Allyn, Inc.2002—
+3K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…Oridion Capnography, Inc.20063
+4K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007—
+5K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20099

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200210
200510
200620
200710
200810
200970
201080
201160
2012150
2013140
2014181
2015130
2016120
2017150
2018150
2019160
2020160
2021110
2022240
2023160
2024200
2025190
2026160
FIG. 1 — Lineage of K911598, 1991–2026Source: 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.

1 device in this family has 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 DRT device

  1. #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 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? (269)

See all 269

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K984033Atlas MonitorWelch Allyn, Inc.1999267
K963400Nellcor Symphony N-3000 Patient Monitor with SPO2 and Ecg and N-3200 Display/PrinterNellcor Puritan Bennett, Inc.19960

Has anything in its family been recalled? (1 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.

  • K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 9 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K984033 (Welch Allyn, Inc., 1999) has gone furthest, with 267 descendants of its own.

How does its category compare?

All DRT devices

DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRT

1in 2025

2007: 12008: 12009: 62010: 32011: 32012: 12013: 12015: 12016: 12017: 12018: 12019: 12021: 22022: 12023: 12024: 32025: 12026 (partial year): 5
2007high 6 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRT

228in 2024

2009: 70 days median2010: 44 days median2011: 149 days median2024: 228 days median2026 (partial year): 120 days median
2007high 228 (2024) · low 44 (2010)2026

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

Recalls per year · DRT

1in 2024

2011: 12021: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRT

40in 2025

2007: 1132008: 992009: 1182010: 632011: 362012: 472013: 162014: 262015: 482016: 552017: 1592018: 2242019: 4472020: 502021: 852022: 352023: 472024: 292025: 40
2007high 447 (2019) · low 16 (2013)2025

MAUDE reports naming product code DRT, 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
20071—0113
20081—099
20096700118
2010344063
20113149136
20121—047
20131—016
20140—026
20151—048
20161—055
20171—0159
20181—0224
20191—0447
20200—050
20212—185
20221—035
20231—047
20243228129
20251—040
202651200—

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149 FDA decisions under this applicant name. See the company

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Recent decisions in DRT

The DRT category page

  • K262447The Circadia CX00 System (CX00)Circadia Health, Inc. · 2026
  • K254058DistaSense (TM) (v1)Life Detection Technologies · 2026
  • K261286The Circadia C300 System (C300)Circadia Health, Inc. · 2026
  • K252676The Circadia C300 System (C300)Circadia Health, Inc. · 2026
  • K253388Sleepiz One+ (Model 2.5)Sleepiz AG · 2026

https://510kreport.com/device/K911598 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911598: Datascope Passport Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911598

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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