510(k) · Cleared
ClearedHemosonic 200HEMODYNAMIC Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DPN Thin Layer Chromatography, Propoxyphene
Cleared on Apr 28, 2004 as substantially equivalent to K031153 (Arrow Intl., Inc., 2003) after a 30-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Apr 28, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- DPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851426 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
- 2 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
- 1 generation backK031153 Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model…Arrow Intl., Inc. · 2003
- This deviceK040802 Hemosonic 200HEMODYNAMIC MonitorArrow Intl., Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851426 | Accucom Cardiac Output Monitor | Lawrence Medical Systems, Inc. | 1985 | — |
| −2 | K972798 | Dynemo 3000 | Sometec, Inc. | 1998 | — |
| −1 | K031153 | Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065 | Arrow Intl., Inc. | 2003 | — |
| 0 (this device) | 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 |
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 DPN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K031153 | Monitor, Model HSM-00200; Probe, Model HSP-05065; Jacket, Model HSJ-05065Summary page 1…gally marketed The predicate device is the jacket used in Arrow International, the devices to which the HemoSonic TM 200 Hemodynamic Monitor cleared under K031153. device is substantially equivalent: Description of the The probe jacket contains the acoustic gel into which the ultr… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All DPN devicesDPN Thin Layer Chromatography, Propoxyphene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPN
FDA has decided no DPN device since 2007.
Median 510(k) review, days · DPN
Too few DPN 510(k)s in any year since 2007 to give a median.
Recalls per year · DPN
No recall names DPN since 2007.
Adverse event reports per year · DPN
1in 2014
MAUDE reports naming product code DPN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HemoSonicTM 200 can be used to observe, diagnose, evaluate, and monitor at-risk patients from 15 to 150 kg by providing hemodynamic information for determining therapeutic actions and maintaining cardiovascular stability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040802 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040802: Hemosonic 200HEMODYNAMIC Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040802
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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