510(k) · Cleared
ClearedBiotrans Reusable Sensor Base 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 Jul 17, 1998 as substantially equivalent to K951129 (Medex, Inc., 1995) and 2 other predicates after a 60-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jul 17, 1998
- Review
- 60 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K951129 (1995). 3 ancestors in all, the oldest K841788 (1985). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951129 | Novatrans II | Medex, Inc. | 1995 | — |
| −1 | K961404 | MX960 Reusable Pressure Transducer | Medex, Inc. | 1996 | 5 |
| 0 (this device) | K981745 | Biotrans Reusable Sensor Base Model Number BT Xxxxxx | Sunscope Intl., Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 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? (3)
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 |
|---|---|---|---|
| * | K951129 | Novatrans IISummary page 1…ansducer Classification Name: Transducer, Blood Pressure, Extravascular 4. Predicate Device(s): Medex Inc.'s (Medex's) MX 860 Novatrans |l reusable pressure transducer (K951129) and MX 960 (K961404), and Utah Medical Products, Inc.’s Monitoring Cables (K841788). 5. Device Description: The BIOTRANS Pres… | 1995 |
| * | K961404 | MX960 Reusable Pressure TransducerSummary page 1…n Name: Transducer, Blood Pressure, Extravascular 4. Predicate Device(s): Medex Inc.'s (Medex's) MX 860 Novatrans |l reusable pressure transducer (K951129) and MX 960 (K961404), and Utah Medical Products, Inc.’s Monitoring Cables (K841788). 5. Device Description: The BIOTRANS Pressure Monitoring System… | 1996 |
| * | K841788 | Utah Disposable Pressure TransducerSummary page 1…Device(s): Medex Inc.'s (Medex's) MX 860 Novatrans |l reusable pressure transducer (K951129) and MX 960 (K961404), and Utah Medical Products, Inc.’s Monitoring Cables (K841788). 5. Device Description: The BIOTRANS Pressure Monitoring System consists of the sterile, single-use BIOTRANS Pressure Monitori… | 1985 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K951129.
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 Sensor Base is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can be displayed using separate monitoring equipment.
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/K981745 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981745: Biotrans Reusable Sensor Base 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/K981745
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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