510(k) · Cleared
ClearedMikro-Cath, Model 825-0101
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 Jan 5, 2010 as substantially equivalent to K792177 (Millar Instruments, Inc., 1979) and 2 other predicates after a 96-day review. Its family tree reaches back 1 generation to 1979. 6 later devices descend from it.
- Decided
- Jan 5, 2010
- Review
- 96 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K792177 (1979). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK792177 Millar Mikro-Tip Catheter TransducerMillar Instruments, Inc. · 1979
- This deviceK093111 Mikro-Cath, Model 825-0101Millar Instruments, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK141275 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK160272 Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK173399 Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017
- Descendant · 4 generations on · 0 of its ownK190098 Endophys Pressure Sensing SheathEndophys Holdings, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK180620 Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141275Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2015 · cites it directly4descendants
- K160272Endophys Pressure Sensing Sheath KitEndophys, Inc. · 2016 · 2 generations on3descendants
- K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC · 2017 · 3 generations on1descendant
- K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC · 2019 · 4 generations on0descendants
- K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792177 | Millar Mikro-Tip Catheter Transducer | Millar Instruments, Inc. | 1979 | — |
| 0 (this device) | K093111 | Mikro-Cath, Model 825-0101 | Millar Instruments, Inc. | 2010 | — |
| +1 | K141275 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2015 | — |
| +2 | K160272 | Endophys Pressure Sensing Sheath Kit | Endophys, Inc. | 2016 | — |
| +3 | K173399 | Endophys Pressure Sensing Sheath Kit- 8F | Endophys Holdings, LLC | 2017 | — |
| +4 | K190098 | Endophys Pressure Sensing Sheath | Endophys Holdings, LLC | 2019 | — |
| +3 | K180620 | Endophys Pressure Sensing Sheath Kit | Endophys Holdings, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 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? (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 |
|---|---|---|---|
| * | K792177 | Millar Mikro-Tip Catheter TransducerSummary page 2…cular Mikro Tip Catheter Transducer Model SPC-330A approved device (reference Millar 5 IOK# K7921 77). Mikro-Cath is a single use sterile device. Same accessories of the… | 1979 |
| * | K952773 | Mikro-Tip Angiographic CatheterSummary page 2…sterilization to Millar Angiographic Catheter single use sterile device. Model SPC-454D approved device under Millar 510K# K952773 Millar Mikro-Cath is substantially equivalent in design and material with… | 1995 |
| * | K914479 | Microsensor Intracranial Pressure TransducerSummary page 2…sign and material with Millar VPM- 10 (Codman & Shurtleff Inc. Microsensor Intracranial Pressure Transducer 510OK # 914479. Discussion of Non-clinical Tests performed: Biocompatibility, sterility, Electromagnetic Compa… | 1994 |
| † | K013205 | Millar Pressure Control Unit Model Pcu-2000 | 2002 |
What descends from it? (6)
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?
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K141275 (Endophys, Inc., 2015) has gone furthest, with 4 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. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Mikro-Cath is a single-use cardiovascular catheter intended to be used for medical research and diagnostic purposes. The catheter is used to measure hemodynamic cardiac pressures in the human body to allow physicians to better understand cardiac health. The catheter would be used as a minimally invasive device under short term limited body contact <24 hours. The typical application will be through the femoral artery with the use of an additional guiding catheter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093111: Mikro-Cath, Model 825-0101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093111
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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