510(k) · Cleared
ClearedPressure Monitoring Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Utah Medical Products, Inc. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Mar 25, 1985 after a 283-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 25, 1985
- Review
- 283 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK842352 Pressure Monitoring KitUtah Medical Products, Inc. · 1985
- Descendant · cites it directly · 1 of its ownK991886 Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line…Pulsion Medical Systems, Inc. · 2000 · Recalled
- Descendant · cites it directly · 0 of its ownK101189 Reavillmed Pressure Monitoring System and PiccReavillmed · 2010
- Descendant · 2 generations on · 0 of its ownK020587 Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor…Pulsion Medical Systems AG · 2002
Most influential descendants
Showing 3 of 3 · See all- K991886Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate SensorPulsion Medical Systems, Inc. · 2000 · cites it directly1descendant
- K101189Reavillmed Pressure Monitoring System and PiccReavillmed · 2010 · cites it directly0descendants
- K020587Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing PV 4046Pulsion Medical Systems AG · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K842352 | Pressure Monitoring Kit | Utah Medical Products, Inc. | 1985 | — |
| +1 | K991886 | Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate… | Pulsion Medical Systems, Inc. | 2000 | 1 |
| +1 | K101189 | Reavillmed Pressure Monitoring System and Picc | Reavillmed | 2010 | — |
| +2 | K020587 | Pulsion Pulsiocath Picco Monitoring Kit, Injectate Sensor Temperature Housing… | Pulsion Medical Systems AG | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
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 DRS? 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 DRS device
- #1 K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ…score 17.4 · 29 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K991886 (Pulsion Medical Systems, Inc., 2000) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRS devicesDRS Transducer, Blood-Pressure, Extravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRS
186in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRS
15in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DRS
187in 2025
MAUDE reports naming product code DRS, 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 | — | 0 | 397 |
| 2008 | 0 | — | 0 | 531 |
| 2009 | 2 | — | 0 | 344 |
| 2010 | 2 | — | 0 | 115 |
| 2011 | 3 | 135 | 0 | 63 |
| 2012 | 1 | — | 0 | 43 |
| 2013 | 1 | — | 0 | 39 |
| 2014 | 1 | — | 0 | 23 |
| 2015 | 1 | — | 0 | 60 |
| 2016 | 3 | 186 | 162 | 89 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 0 | — | 11 | 82 |
| 2019 | 0 | — | 0 | 84 |
| 2020 | 0 | — | 0 | 41 |
| 2021 | 0 | — | 0 | 93 |
| 2022 | 0 | — | 0 | 95 |
| 2023 | 1 | — | 15 | 147 |
| 2024 | 0 | — | 0 | 205 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 1 | — | 2 (2) | — |
https://510kreport.com/device/K842352 · printed Nov 5, 2026
Cite this page
510(k) Report. “K842352: Pressure Monitoring Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K842352
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026