510(k) · Cleared
ClearedBIOTEQ Drainage Catheter Set (One Step Type)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioteque Corporation · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Oct 9, 2020 as substantially equivalent to K053245 (Uresil, LLC, 2005) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Oct 9, 2020
- Review
- 266 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003753 (2001). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK003753 GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with…Uresil Corp. · 2001
- 1 generation backK033862 Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without…Bioteque Corp. · 2005
- This deviceK200103 BIOTEQ Drainage Catheter Set (One Step Type)Bioteque Corporation · 2020
- Descendant · cites it directly · 2 of its ownK210419 BIOTEQ Drainage Catheter BT-PDS-seriesBioteque Corporation · 2022
- Descendant · cites it directly · 0 of its ownK254179 Drainage CatheterCanyon Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251019 BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GBioteque Corporation · 2025
Most influential descendants
Showing 3 of 3 · See all- K210419BIOTEQ Drainage Catheter BT-PDS-seriesBioteque Corporation · 2022 · cites it directly2descendants
- K254179Drainage CatheterCanyon Medical, Inc. · 2026 · cites it directly0descendants
- K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GBioteque Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003753 | GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking… | Uresil Corp. | 2001 | — |
| −1 | K033862 | Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety… | Bioteque Corp. | 2005 | — |
| 0 (this device) | K200103 | BIOTEQ Drainage Catheter Set (One Step Type) | Bioteque Corporation | 2020 | — |
| +1 | K210419 | BIOTEQ Drainage Catheter BT-PDS-series | Bioteque Corporation | 2022 | — |
| +1 | K254179 | Drainage Catheter | Canyon Medical, Inc. | 2026 | — |
| +1 | K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K053245 | GP General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy Catheter…Summary page 5…2/6 Page 2 of 5 K200103 BIOTEQUE CORPORATION Traditional 510(k) BIOTEQ Drainage Catheter Set (One Step Type) Section 5 - 510 (k) Summary 510(k) Number: K053245 5.6 Identification of the Predicate Device I1: Predicate Device Name: BIOTEQ" Pigtail Drainage Catheter Set (One Step Type) Manuf… | 2005 |
| * | K033862 | Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String LockSummary page 5…e Step Type) Manufacturer: BIOTEQUE CORPORATION Classification Product Code: LHI Subsequent Product Code: NEP Regulation number: 880.5440 Device Class: I 510(k) Number: K033862 5.7 Intended Use The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst… | 2005 |
What descends from it? (3)
3 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 19 years and passes through 3 companies; a new generation was cleared every 15.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K210419 (Bioteque Corporation, 2022) has gone furthest, with 2 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. 2020, this device’s year, is highlighted.
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?
The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200103: BIOTEQ Drainage Catheter Set (One Step Type).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200103
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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