510(k) · Cleared
ClearedEnabler-P Catheter, 1000 Part Number:1160
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocross, Ltd. · DQY Catheter, Percutaneous
Cleared on May 22, 2009 as substantially equivalent to K082339 (Endocross, Ltd., 2008) and 1 other predicate after a 150-day review. Its family tree reaches back 6 generations to 2000. 12 later devices descend from it.
- Decided
- May 22, 2009
- Review
- 150 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001992 (2000). 8 ancestors in all, the oldest K972744 (1997). 12 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 5 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 4 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 3 generations backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- 2 generations backK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- 1 generation backK082339 Enabler-P Support CatheterEndocross, Ltd. · 2008
- This deviceK083833 Enabler-P Catheter, 1000 Part Number:1160Endocross, Ltd. · 2009
- Descendant · cites it directly · 9 of its ownK092174 Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009
- Descendant · 2 generations on · 8 of its ownK121763 Multicross Support CatheterRoxwood Medical, Inc. · 2012
- Descendant · 3 generations on · 3 of its ownK140910 Centercross CatheterRoxwood Medical, Inc. · 2014
- Descendant · 4 generations on · 2 of its ownK152456 CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016
- Descendant · 3 generations on · 2 of its ownK143608 NovaCross MicrocatheterNitiloop, Ltd. · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K092174Enabler-P Catheter System, Model 3000Endocross, Ltd. · 2009 · cites it directly9descendants
- K121763Multicross Support CatheterRoxwood Medical, Inc. · 2012 · 2 generations on8descendants
- K140910Centercross CatheterRoxwood Medical, Inc. · 2014 · 3 generations on3descendants
- K152456CenterCross Ultra CatheterRoxwood Medical, Inc. · 2016 · 4 generations on2descendants
- K143608NovaCross MicrocatheterNitiloop, Ltd. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −5 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −4 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −3 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| −2 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| −1 | K082339 | Enabler-P Support Catheter | Endocross, Ltd. | 2008 | — |
| 0 (this device) | K083833 | Enabler-P Catheter, 1000 Part Number:1160 | Endocross, Ltd. | 2009 | — |
| +1 | K092174 | Enabler-P Catheter System, Model 3000 | Endocross, Ltd. | 2009 | — |
| +2 | K121763 | Multicross Support Catheter | Roxwood Medical, Inc. | 2012 | — |
| +3 | K140910 | Centercross Catheter | Roxwood Medical, Inc. | 2014 | — |
| +4 | K152456 | CenterCross Ultra Catheter | Roxwood Medical, Inc. | 2016 | — |
| +3 | K143608 | NovaCross Microcatheter | Nitiloop, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K082339 | Enabler-P Support CatheterSummary page 1…eous Catheter Classification Name: Percutaneous Catheter, DQY / 21 CFR 870.1250 Predicate Devices * ENABLER-P Support Catheter manufactured by Endocross (K082339) * Asahi Tormus Support Catheter manufactured by Asahi Inteec (KO51772) Intended Use / Indications for Use… | 2008 |
| * | K051772 | Asahi Tornus Support Catheter | 2005 |
What descends from it? (12)
See all 122 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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K092174 (Endocross, Ltd., 2009) has gone furthest, with 9 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 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/K083833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083833: Enabler-P Catheter, 1000 Part Number:1160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083833
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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