510(k) · Cleared
ClearedMillar Mikro-Tip Catheter Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millar Instruments, Inc. · DXO Transducer, Pressure, Catheter Tip
Cleared on Nov 15, 1979 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Nov 15, 1979
- Review
- 16 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK792177 Millar Mikro-Tip Catheter TransducerMillar Instruments, Inc. · 1979
- Descendant · cites it directly · 6 of its ownK093111 Mikro-Cath, Model 825-0101Millar Instruments, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK141275 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK160272 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016
- Descendant · 4 generations on · 1 of its ownK173399 Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017
- Descendant · 5 generations on · 0 of its ownK190098 Endophys Pressure Sensing SheathEndophys Holdings, LLC · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K093111Mikro-Cath, Model 825-0101Millar Instruments, Inc. · 2010 · cites it directly6descendants
- K141275Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015 · 2 generations on4descendants
- K160272Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016 · 3 generations on3descendants
- K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017 · 4 generations on1descendant
- K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC · 2019 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K792177 | Millar Mikro-Tip Catheter Transducer | Millar Instruments, Inc. | 1979 | — |
| +1 | K093111 | Mikro-Cath, Model 825-0101 | Millar Instruments, Inc. | 2010 | — |
| +2 | K141275 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2015 | — |
| +3 | K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2016 | — |
| +4 | K173399 | Endophys Pressure Sensing Sheath Kit- 8F | Endophys Holdings, LLC | 2017 | — |
| +5 | K190098 | Endophys Pressure Sensing Sheath | Endophys Holdings, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 DXO? 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 DXO device
- #1 K241418 OptoMonitor 3score 14.8 · 11 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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093111 | Mikro-Cath, Model 825-0101 | 2010 | 6 |
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, K093111 (Millar Instruments, Inc., 2010) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXO
120in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXO
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXO
183in 2025
MAUDE reports naming product code DXO, 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 | 3 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 74 |
| 2011 | 1 | — | 0 | 111 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 93 |
| 2014 | 3 | 176 | 0 | 85 |
| 2015 | 2 | — | 1 | 114 |
| 2016 | 2 | — | 0 | 152 |
| 2017 | 2 | — | 0 | 186 |
| 2018 | 1 | — | 0 | 179 |
| 2019 | 4 | 120 | 0 | 153 |
| 2020 | 2 | — | 0 | 158 |
| 2021 | 0 | — | 0 | 116 |
| 2022 | 1 | — | 0 | 144 |
| 2023 | 0 | — | 0 | 194 |
| 2024 | 1 | — | 0 | 197 |
| 2025 | 1 | — | 0 | 183 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K792177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K792177: Millar Mikro-Tip Catheter Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K792177
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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