510(k) Report

510(k) · Cleared

Cleared

Ambulatory Blood Pressure Monitor Spacelabs #90202

K855127510(k) TraditionalCleared Aug 14, 1986234-day reviewClass II21 CFR 870.1130

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

Spacelabs, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Aug 14, 1986 after a 234-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 64 later devices descend from it.

Decided
Aug 14, 1986
Review
234 days
Class
Class II
Product code
DXN
Recalls
None
Predicates
0

64 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2006: 1 descendant cleared1999: 2 descendants cleared2011: 2 descendants cleared2003: 1 descendant cleared2007: 2 descendants cleared2014: 7 descendants cleared2018: 1 descendant cleared2010: 1 descendant cleared2002: 2 descendants cleared2001: 1 descendant cleared2012: 2 descendants cleared2008: 2 descendants cleared2017: 3 descendants cleared2015: 3 descendants cleared2019: 3 descendants cleared2016: 4 descendants cleared2025: 5 descendants cleared2023: 4 descendants cleared2022: 3 descendants cleared2024: 3 descendants cleared2026: 9 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK855127 Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc. · 1986
  2. Descendant · cites it directly · 26 of its ownK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
  3. Descendant · cites it directly · 21 of its ownK031479 Ambulatory Blood Pressure (Abp) 92506 Report Management System…Datex-Ohmeda, Inc. · 2003
  4. Descendant · 2 generations on · 20 of its ownK080192 Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
  5. Descendant · cites it directly · 19 of its ownK060315 Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd. · 2006
  6. Descendant · 3 generations on · 17 of its ownK132036 Hypervisor Central Monitoring System (Including Telemetry Monitoring…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

1999: 22001: 12002: 22003: 12004: 12006: 12007: 22008: 22010: 12011: 22012: 22014: 72015: 32016: 42017: 32018: 12019: 32020: 12021: 12022: 32023: 42024: 32025: 52026: 9
1999high 9 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 64 · See all
  • K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999 · cites it directly26descendants
  • K031479Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506Datex-Ohmeda, Inc. · 2003 · cites it directly21descendants
  • K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on20descendants
  • K060315Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd. · 2006 · cites it directly19descendants
  • K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · 3 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K855127Ambulatory Blood Pressure Monitor Spacelabs #90202Spacelabs, Inc.1986—
+1K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc.1999—
+1K031479Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model…Datex-Ohmeda, Inc.2003—
+2K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082
+1K060315Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd.2006—
+3K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200110
200220
200310
200410
200610
200720
200820
201010
201120
201220
201470
201530
201640
201730
201810
201930
202010
202110
202230
202340
202430
202550
202690
FIG. 1 — Lineage of K855127, 1986–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXN? 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 DXN device

  1. #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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? (64)

See all 64

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

NumberDeviceApplicantDecidedDescendants
K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc.199926
K031479Ambulatory Blood Pressure (Abp) 92506 Report Management System (RMS), Model 92506Datex-Ohmeda, Inc.200321
K060315Healthstats Bpro Ambulatory Blood Pressure Monitoring SystemHealthstats International Pte., Ltd.200619
K964235Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp ControlIndustrielle Entwicklung Medizintechnik Und Vertri199914
K103732Spacelabs Model 90217A Ambulatory Blood Pressure (Abp) MonitorSpacelabs Healthcare, Ltd.20111
K041169Piesometer, Model MK-1Canamet Canadian Natl Medical Technologies, Inc.20040

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, K983996 (Spacelabs Medical, Inc., 1999) has gone furthest, with 26 descendants of its own.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXN

28in 2025

2007: 272008: 232009: 462010: 432011: 342012: 362013: 342014: 292015: 302016: 302017: 332018: 222019: 332020: 242021: 232022: 252023: 352024: 172025: 282026 (partial year): 29
2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007: 118 days median2008: 82 days median2009: 73 days median2010: 94 days median2011: 72 days median2012: 116 days median2013: 150 days median2014: 133 days median2015: 97 days median2016: 144 days median2017: 184 days median2018: 235 days median2019: 156 days median2020: 198 days median2021: 190 days median2022: 137 days median2023: 182 days median2024: 107 days median2025: 142 days median2026 (partial year): 147 days median
2007high 235 (2018) · low 72 (2011)2026

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

Recalls per year · DXN

3in 2024

2008: 12009: 32011: 12013: 12016: 12019: 12024: 3
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DXN

239in 2025

2007: 212008: 82009: 172010: 142011: 102012: 192013: 722014: 472015: 622016: 542017: 902018: 6172019: 962020: 1302021: 1622022: 1552023: 1622024: 2702025: 239
2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, 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
200727118021
2008238218
20094673317
20104394014
20113472110
201236116019
201334150172
201429133047
20153097062
201630144154
201733184090
2018222350617
201933156196
2020241980130
2021231900162
2022251370155
2023351820162
2024171073270
2025281420239
2026291470—

More from Spacelabs, Inc.

46 FDA decisions under this applicant name. See the company

  • K954962Spacelabs Medical Multigas AnalyzerSpacelabs, Inc. · 1996
  • K951605Spacelabs Medical Casemaster Information Management SystemSpacelabs, Inc. · 1995
  • K950779Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
  • K941165Comet Capnograph ModuleSpacelabs, Inc. · 1994
  • K923788Space Labs Model 90560Spacelabs, Inc. · 1993

Recent decisions in DXN

The DXN category page

  • K260470Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C…Shenzhen Brav Electronic Technologies Co., Ltd. · 2026
  • K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc. · 2026
  • K254000Happy Health Blood Pressure MonitorHappy Health, Inc. · 2026
  • K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd. · 2026
  • K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus…JOYTECH Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K855127 · printed Nov 6, 2026

Cite this page

510(k) Report. “K855127: Ambulatory Blood Pressure Monitor Spacelabs #90202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K855127

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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