510(k) · Cleared
ClearedMonitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Nov 25, 2003 as substantially equivalent to K972798 (Sometec, Inc., 1998) after a 228-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Nov 25, 2003
- Review
- 228 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K851426 (1985). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 1 generation backK972798 Dynemo 3000Sometec, Inc. · 1998
- This deviceK031153 Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model…Arrow Intl., Inc. · 2003
- Descendant · cites it directly · 0 of its ownK040802 Hemosonic 200HEMODYNAMIC MonitorArrow Intl., Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040802Hemosonic 200HEMODYNAMIC MonitorArrow Intl., Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −1 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| 0 (this device) | K031153 | Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065 | Arrow Intl., Inc. | 2003 | — |
| +1 | K040802 | Hemosonic 200HEMODYNAMIC Monitor | Arrow Intl., Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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 DPW? 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972798 | Dynemo 3000Summary page 1…R, name: DPW. at 21 CFR 870.2100 Legally marketed devices Sometec - Dynemo 3000 Non-Invasive Hemodynamic to which the device is Diagnostic Device (K972798) substantially equivalent: Description of device: The HemoSonicTM200 is a monitoring device that non-… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040802 | Hemosonic 200HEMODYNAMIC Monitor | 2004 | 0 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K040802 (Arrow Intl., Inc., 2004) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K972798.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | 1 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031153: Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031153
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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