510(k) · Cleared
ClearedEnabler-P Catheter System, Model 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocross, Ltd. · DQY Catheter, Percutaneous
Cleared on Dec 30, 2009 as substantially equivalent to K082339 (Endocross, Ltd., 2008) and 3 other predicates after a 162-day review. Its family tree reaches back 7 generations to 2000. 9 later devices descend from it.
- Decided
- Dec 30, 2009
- Review
- 162 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K001992 (2000). 11 ancestors in all, the oldest K942269 (1994). 9 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 6 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 5 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 4 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 3 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 2 generations backK082339 Enabler-P Support CatheterEndocross, Ltd. · 2008
- 1 generation backK083833 Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd. · 2009
- This deviceK092174 Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009
- Descendant · cites it directly · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK140910 Centercross CatheterRoxwood Medical, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK152456 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK143608 NovaCross MicrocatheterNitiloop, Ltd. · 2015
- Descendant · 4 generations on · 1 of its ownK160681 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · cites it directly8descendants
- K140910Centercross CatheterRoxwood Medical, Inc. · 2014 · 2 generations on3descendants
- K152456CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 3 generations on2descendants
- K143608NovaCross MicrocatheterNitiloop, Ltd. · 2015 · 2 generations on2descendants
- K160681CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −6 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −5 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −4 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −3 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −2 | K082339 | Enabler-P Support Catheter | Endocross, Ltd. | 2008 | — |
| −1 | K083833 | Enabler-P Catheter, 1000 Part Number:1160 | Endocross, Ltd. | 2009 | — |
| 0 (this device) | K092174 | Enabler-P Catheter System, Model 3000 | Endocross, Ltd. | 2009 | — |
| +1 | K121763 | Multicross Support Catheter | Roxwood Medical, Inc. | 2012 | — |
| +2 | K140910 | Centercross Catheter | Roxwood Medical, Inc. | 2014 | — |
| +3 | K152456 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016 | — |
| +2 | K143608 | NovaCross Microcatheter | Nitiloop, Ltd. | 2015 | — |
| +4 | K160681 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K082339 | Enabler-P Support CatheterSummary page 1…neous Catheter System Classification Name: Percutaneous Catheter, DQY / 21 CFR 870.1250 Predicate Devices * ENABLER-P Catheter manufactured by Endocross (K082339, K083833) * Metricath System manufactured by Angiometrx Inc (K024000) * Everest 20cc Inflation Device manufactured by M… | 2008 |
| * | K083833 | Enabler-P Catheter, 1000 Part Number:1160Summary page 1…heter System Classification Name: Percutaneous Catheter, DQY / 21 CFR 870.1250 Predicate Devices * ENABLER-P Catheter manufactured by Endocross (K082339, K083833) * Metricath System manufactured by Angiometrx Inc (K024000) * Everest 20cc Inflation Device manufactured by Medtronic… | 2009 |
| * | K942269 | Medtronic Everest Inflation DeviceSummary page 1…factured by Endocross (K082339, K083833) * Metricath System manufactured by Angiometrx Inc (K024000) * Everest 20cc Inflation Device manufactured by Medtronic (K942269) Intended Use / Indications for Use The ENABLER-P Catheter System is intended to be used in conjunction with a s… | 1994 |
| * | K024000 | Metricath System Comprised of Metricath 1000 Console & Metricath Balloon CatheterSummary page 1…DQY / 21 CFR 870.1250 Predicate Devices * ENABLER-P Catheter manufactured by Endocross (K082339, K083833) * Metricath System manufactured by Angiometrx Inc (K024000) * Everest 20cc Inflation Device manufactured by Medtronic (K942269) Intended Use / Indications for Use The… | 2003 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121763 | Multicross Support Catheter | 2012 | 8 |
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 9 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K121763 (Roxwood Medical, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K082339.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The ENABLER-P Catheter System is intended to be used in conjunction with a
steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire
exchange.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092174: Enabler-P Catheter System, Model 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092174
Report an extraction error
Are you the manufacturer?
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