510(k) · Cleared
ClearedBioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioteque Corp. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Feb 14, 2005 as substantially equivalent to K003753 (Uresil Corp., 2001) after a 430-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Feb 14, 2005
- Review
- 430 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003753 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003753 GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with…Uresil Corp. · 2001
- This deviceK033862 Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without…Bioteque Corp. · 2005
- Descendant · cites it directly · 3 of its ownK200103 BIOTEQ Drainage Catheter Set (One Step Type)Bioteque Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK210419 BIOTEQ Drainage Catheter BT-PDS-seriesBioteque Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK254179 Drainage CatheterCanyon Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251019 BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GBioteque Corporation · 2025
Most influential descendants
Showing 4 of 4 · See all- K200103BIOTEQ Drainage Catheter Set (One Step Type)Bioteque Corporation · 2020 · cites it directly3descendants
- K210419BIOTEQ Drainage Catheter BT-PDS-seriesBioteque Corporation · 2022 · 2 generations on2descendants
- K254179Drainage CatheterCanyon Medical, Inc. · 2026 · 2 generations on0descendants
- K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GBioteque Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003753 | GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking… | Uresil Corp. | 2001 | — |
| 0 (this device) | K033862 | Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety… | Bioteque Corp. | 2005 | — |
| +1 | K200103 | BIOTEQ Drainage Catheter Set (One Step Type) | Bioteque Corporation | 2020 | — |
| +2 | K210419 | BIOTEQ Drainage Catheter BT-PDS-series | Bioteque Corporation | 2022 | — |
| +2 | K254179 | Drainage Catheter | Canyon Medical, Inc. | 2026 | — |
| +2 | K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K003753 | GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, GP…Summary page 1…s I1 by 4. Predicate Device: URESIL General Purpose Drainage Set (k003753) marketed URESIL CORP.… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type) | 2020 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K200103 (Bioteque Corporation, 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
BIOTEQ® Pigtail Drainage Catheter Set (One Step Type) is intended to be used for percutaneous drainage of abscesses, cysts, gall bladders and nephrostomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033862: Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033862
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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