510(k) · Cleared
ClearedBiotrans Pressure Monitoring Kit Model Number BT Xxxxxx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunscope Intl., Inc. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Aug 20, 1998 after a 94-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 20, 1998
- Review
- 94 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK981747 Biotrans Pressure Monitoring Kit Model Number BT XxxxxxSunscope Intl., Inc. · 1998
- Descendant · cites it directly · 2 of its ownK070710 Accutrans Disposable Pressure Monitoring SystemBiosensors International-USA · 2007
- Descendant · 2 generations on · 0 of its ownK151040 Art-line Single channel blood pressure system, Art-line Double…Biometrix, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK102033 Combitrans Monitoring Sets and AccessoriesB.Braun Melsungen AG · 2011
Most influential descendants
Showing 3 of 3 · See all- K070710Accutrans Disposable Pressure Monitoring SystemBiosensors International-USA · 2007 · cites it directly2descendants
- K151040Art-line Single channel blood pressure system, Art-line Double channel blood pressure…Biometrix, Ltd. · 2015 · 2 generations on0descendants
- K102033Combitrans Monitoring Sets and AccessoriesB.Braun Melsungen AG · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981747 | Biotrans Pressure Monitoring Kit Model Number BT Xxxxxx | Sunscope Intl., Inc. | 1998 | — |
| +1 | K070710 | Accutrans Disposable Pressure Monitoring System | Biosensors International-USA | 2007 | — |
| +2 | K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood… | Biometrix, Ltd. | 2015 | — |
| +2 | K102033 | Combitrans Monitoring Sets and Accessories | B.Braun Melsungen AG | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 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? (4)
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 |
|---|---|---|---|
| * | — | Medex, Inc.’s Medex MX-960 Named without a submission number | |
| * | — | Medex, Inc.’s Medex MX-860 Named without a submission number | |
| * | — | Utah Medical Products Inc.’s Pressure Monitoring Kits Named without a submission number | |
| * | — | Ohmeda’s DTX Disposable Transducer Kits Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070710 | Accutrans Disposable Pressure Monitoring System | 2007 | 2 |
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, K070710 (Biosensors International-USA, 2007) has gone furthest, with 2 descendants 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) | — |
What is it indicated for?
The BSI BIOTRANS Pressure Monitoring Kits are designed for use with BIOTRANS Sensor Bases.
Kits containing integral 3- and 40 cc/hr flush device are designed for use in physiologic pressure measurements where continuous flow is required to maintain catheter patency, The 40 cc/hr flush devices are included in Kits designed for neonatal applications in conjunction with a properly calibrated fluid delivery pump.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981747 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981747: Biotrans Pressure Monitoring Kit Model Number BT Xxxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981747
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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