510(k) · Cleared
ClearedSlip-Coat (TM) Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jul 28, 1988 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 16 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.
- Decided
- Jul 28, 1988
- Review
- 22 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly. 4 of the 16 devices in this family, counting this one, have a Class I recall.
- This deviceK882796 Slip-Coat (TM) CathetersCook, Inc. · 1988
- Descendant · cites it directly · 9 of its ownK122937 Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle…Cook, Inc. · 2012 · Recalled (Class I)
- Descendant · cites it directly · 4 of its ownK071468 Clarivein CatheterVascular Insights, LLC · 2008 · Recalled
- Descendant · 2 generations on · 3 of its ownK153502 ClariVein ICVascular Insights, LLC · 2016
- Descendant · 3 generations on · 2 of its ownK201907 ClariVein ICMerit Medical Systems, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK162448 White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava…Cook Incorporated · 2017 · Recalled (Class I)
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133130 Beacon Tip Torcon NB Advantage Catheter, Torcon…cites it directly · 2015
- K122937 Slip-Cath Beacon Tip Catheter Model SCBR…cites it directly · 2012
- K162448 White Sizing Catheter, Aurous Centimeter Sizing…2 generations on · 2017
- K173289 Beacon Tip Torcon NB Advantage Catheter…2 generations on · 2017
Most influential descendants
Showing 5 of 15 · See all- K122937Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath…Cook, Inc. · 2012 · cites it directly9descendants
- K071468Clarivein CatheterVascular Insights, LLC · 2008 · cites it directly4descendants
- K153502ClariVein ICVascular Insights, LLC · 2016 · 2 generations on3descendants
- K201907ClariVein ICMerit Medical Systems, Inc. · 2020 · 3 generations on2descendants
- K162448White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing CatheterCook Incorporated · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K882796 | Slip-Coat (TM) Catheters | Cook, Inc. | 1988 | — |
| +1 | K122937 | Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select… | Cook, Inc. | 2012 | Class I |
| +1 | K071468 | Clarivein Catheter | Vascular Insights, LLC | 2008 | 1 |
| +2 | K153502 | ClariVein IC | Vascular Insights, LLC | 2016 | — |
| +3 | K201907 | ClariVein IC | Merit Medical Systems, Inc. | 2020 | — |
| +2 | K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing… | Cook Incorporated | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 1 |
| 2015 | 1 | 1 |
| 2016 | 2 | 0 |
| 2017 | 2 | 2 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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.
4 devices in this family have a Class I recall. 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133130Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K122937Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR…Cook, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K162448White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing CatheterCook Incorporated · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K173289Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath…Cook Incorporated · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K122937 (Cook, Inc., 2012) has gone furthest, with 9 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
https://510kreport.com/device/K882796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K882796: Slip-Coat (TM) Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882796
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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