510(k) · Cleared
ClearedAccutrans Disposable Pressure Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosensors International-USA · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Apr 19, 2007 as substantially equivalent to K981747 (Sunscope Intl., Inc., 1998) and 1 other predicate after a 36-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Apr 19, 2007
- Review
- 36 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K841788 (1985). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK841788 Utah Disposable Pressure TransducerUtah Medical Products, Inc. · 1985
- This deviceK070710 Accutrans Disposable Pressure Monitoring SystemBiosensors International-USA · 2007
- Descendant · cites it directly · 0 of its ownK151040 Art-line Single channel blood pressure system, Art-line Double…Biometrix, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK102033 Combitrans Monitoring Sets and AccessoriesB.Braun Melsungen AG · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841788 | Utah Disposable Pressure Transducer | Utah Medical Products, Inc. | 1985 | — |
| 0 (this device) | K070710 | Accutrans Disposable Pressure Monitoring System | Biosensors International-USA | 2007 | — |
| +1 | K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood… | Biometrix, Ltd. | 2015 | — |
| +1 | K102033 | Combitrans Monitoring Sets and Accessories | B.Braun Melsungen AG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K981747 | Biotrans Pressure Monitoring Kit Model Number BT XxxxxxSummary page 1…essure Monitoring System Classification Name: Transducer, Blood-Pressure, Extravascular 3. Predicate Devices 1. BIOTRANS TM PRESSURE MONITORING KIT (K981747) 2. UTAH DISPOSABLE PRESSURE TRANSDUCER (K841788) 4. Device Description Biosensors's Accutrans Disposable Pressure Tran… | 1998 |
| * | K841788 | Utah Disposable Pressure TransducerSummary page 1…Transducer, Blood-Pressure, Extravascular 3. Predicate Devices 1. BIOTRANS TM PRESSURE MONITORING KIT (K981747) 2. UTAH DISPOSABLE PRESSURE TRANSDUCER (K841788) 4. Device Description Biosensors's Accutrans Disposable Pressure Transducer System consists of a pressure monitoring… | 1985 |
What descends from it? (2)
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K151040 (Biometrix, Ltd., 2015) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.
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?
Accutrans Disposable Pressure Transducer Kit provides the fluid pathway components that are intended to convert the hemodynamic waveform from the patient's catheter, through the disposable pressure transducer with integrated pressure sensor, Into electrical signals which can be displayed using separate monitoring equipment The whole kit is fully disposable and consists of pressure monitoring lines and the Accutrans Disposable Pressure Transducer.…
Read the full statement (222 words)
Accutrans Disposable Pressure Transducer Kit provides the fluid pathway components that are intended to convert the hemodynamic waveform from the patient's catheter, through the disposable pressure transducer with integrated pressure sensor, Into electrical signals which can be displayed using separate monitoring equipment The whole kit is fully disposable and consists of pressure monitoring lines and the Accutrans Disposable Pressure Transducer. :
Accutrans Disposable Pressure Transducer,The disposable pressure transducer is provided with or without an integral 3cc/hr or 30cc/hr flush devices. Kits with 30cc/hrl flush devices are designed exclusively for use with a Infusion pump for neonatal and infant applications. The disposable pressure transducer, with the integrated pressure sensor, is Intended for direct coupling to sterile catheters with fluid (saline) flows in contact with the patient bloodstream.'Accutrans Disposable Pressure Transducer Kits are available for modular assembly of an IV pole-mount transducer organizer system, or for portable on-patient mounting.
Accu Trans Pressure Monitoring Kfs and Accu Trans Disposable Transducer are Indirectly in contact with the blood path and hence, are supplied sterile and Is intended for single use only. Pole-mounts, backplates and transducer adapter cables are accessories that are to be used externally outside the human body, and hence supplied non-sterile but hygienically clean. Between surgical cases of patient. suitable cleaning instructions should be followed to minimize cross contaminatIon between patient and health worker.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070710: Accutrans Disposable Pressure Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070710
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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