510(k) · Cleared
ClearedNovatrans II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medex, Inc. · DRS Transducer, Blood-Pressure, Extravascular
Cleared on Apr 5, 1995 after a 23-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 5, 1995
- Review
- 23 days
- Class
- Class II
- Product code
- DRS
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK951129 Novatrans IIMedex, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK961404 MX960 Reusable Pressure TransducerMedex, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 0 of its ownK221782 Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK981745 Biotrans Reusable Sensor Base Model Number BT XxxxxxSunscope Intl., Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K961404MX960 Reusable Pressure TransducerMedex, Inc. · 1996 · cites it directly2descendants
- K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte., Ltd. · 2023 · 2 generations on0descendants
- K981745Biotrans Reusable Sensor Base Model Number BT XxxxxxSunscope Intl., Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951129 | Novatrans II | Medex, Inc. | 1995 | — |
| +1 | K961404 | MX960 Reusable Pressure Transducer | Medex, Inc. | 1996 | 5 |
| +2 | K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte., Ltd. | 2023 | — |
| +1 | K981745 | Biotrans Reusable Sensor Base Model Number BT Xxxxxx | Sunscope Intl., Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2023 | 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 lists a 510(k) statement for it but has not posted the file, 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, K961404 (Medex, Inc., 1996) 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) | — |
https://510kreport.com/device/K951129 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951129: Novatrans II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951129
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026