510(k) · Cleared

Cleared

Dinamap Pro 1000 Monitor, Model 1000

K002248510(k) TraditionalCleared Sep 21, 200058-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

Critikon Company, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Sep 21, 2000 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 32 devices in its family, counting itself, has a Class I recall. 31 later devices descend from it.

Decided: Sep 21, 2000
Review: 58 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 0

31 later devices descend from it, 3 citing it directly. 1 of the 32 devices in this family, counting this one, has a Class I recall.

This deviceK002248 Dinamap Pro 1000 Monitor, Model 1000Critikon Company, LLC · 2000
Descendant · cites it directly · 27 of its ownK012915 Dinamap Pro 1000 Monitor, Model 1000Ge Medical Systems Information Technologies · 2002 · Recalled
Descendant · 2 generations on · 23 of its ownK022834 Dinamap Pro 1000 Monitor with Superstat, Model 1000Ge Medical Systems Information Technologies · 2003
Descendant · 3 generations on · 20 of its ownK073203 Carescape V100Ge Medical Systems Information Technologies · 2007
Descendant · 4 generations on · 11 of its ownK102426 Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010
Descendant · 4 generations on · 10 of its ownK120598 Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2002high 4 (2017) · low 0 (2004)2026

Class I recalls in this family

K133576 Monitor B406 generations on · 2014

Most influential descendants

Showing 5 of 31 · See all

K012915Dinamap Pro 1000 Monitor, Model 1000Ge Medical Systems Information Technologies · 2002 · cites it directly27descendants
K022834Dinamap Pro 1000 Monitor with Superstat, Model 1000Ge Medical Systems Information Technologies · 2003 · 2 generations on23descendants
K073203Carescape V100Ge Medical Systems Information Technologies · 2007 · 3 generations on20descendants
K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies · 2010 · 4 generations on11descendants
K120598Procare Monitor B40Ge Medical Systems China Co., Ltd. · 2012 · 4 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002248	Dinamap Pro 1000 Monitor, Model 1000	Critikon Company, LLC	2000	—
+1	K012915	Dinamap Pro 1000 Monitor, Model 1000	Ge Medical Systems Information Technologies	2002	1
+2	K022834	Dinamap Pro 1000 Monitor with Superstat, Model 1000	Ge Medical Systems Information Technologies	2003	—
+3	K073203	Carescape V100	Ge Medical Systems Information Technologies	2007	—
+4	K102426	Carescape Model V100 Vital Signs Monitor	Ge Medical Systems Information Technologies	2010	—
+4	K120598	Procare Monitor B40	Ge Medical Systems China Co., Ltd.	2012	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	2	0
2005	1	0
2007	2	0
2008	1	0
2009	1	0
2010	1	0
2012	1	0
2013	2	0
2014	2	1
2015	3	0
2016	1	0
2017	4	0
2018	1	0
2019	1	0
2020	2	0
2022	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K002248, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DXN device

#1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
#2 Held for the reportin the report
#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? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K012915	Dinamap Pro 1000 Monitor, Model 1000	Ge Medical Systems Information Technologies	2002	27
K020022	Dinamap Pro Series Monitor, Models 110, 210, 310, 410	Ge Medical Systems Information Technologies	2002	1
K160667	Anybattery C2 Rechargeable Battery	Anybattery, Inc.	2017	0

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.

K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K012915 (Ge Medical Systems Information Technologies, 2002) has gone furthest, with 27 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

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

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

Recalls per year · DXN

3in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	27	118	0	21
2008	23	82	1	8
2009	46	73	3	17
2010	43	94	0	14
2011	34	72	1	10
2012	36	116	0	19
2013	34	150	1	72
2014	29	133	0	47
2015	30	97	0	62
2016	30	144	1	54
2017	33	184	0	90
2018	22	235	0	617
2019	33	156	1	96
2020	24	198	0	130
2021	23	190	0	162
2022	25	137	0	155
2023	35	182	0	162
2024	17	107	3	270
2025	28	142	0	239
2026	29	147	0	—

https://510kreport.com/device/K002248 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002248: Dinamap Pro 1000 Monitor, Model 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002248

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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