510(k) · Cleared
ClearedTandemrx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · GCJ Laparoscope, General & Plastic Surgery
Cleared on Feb 10, 1997 after a 34-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Feb 10, 1997
- Review
- 34 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK970054 TandemrxBoston Scientific Corp · 1997
- Descendant · cites it directly · 6 of its ownK010610 Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Boston Scientific Corp · 2001
- Descendant · 2 generations on · 4 of its ownK040137 Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK213483 SnapLoc Wire LockWilson Cook Medical · 2022
- Descendant · 3 generations on · 0 of its ownK220247 Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK210353 AutoCap RXBoston Scientific Corporation · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K010610Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Boston Scientific Corp · 2001 · cites it directly6descendants
- K040137Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc. · 2004 · 2 generations on4descendants
- K213483SnapLoc Wire LockWilson Cook Medical · 2022 · 3 generations on0descendants
- K220247Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022 · 3 generations on0descendants
- K210353AutoCap RXBoston Scientific Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970054 | Tandemrx | Boston Scientific Corp | 1997 | — |
| +1 | K010610 | Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527 | Boston Scientific Corp | 2001 | — |
| +2 | K040137 | Wilson-Cook Usw Cap and Wire Lock | Wilson-Cook Medical, Inc. | 2004 | — |
| +3 | K213483 | SnapLoc Wire Lock | Wilson Cook Medical | 2022 | — |
| +3 | K220247 | Guidewire Locking Device | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| +2 | K210353 | AutoCap RX | Boston Scientific Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | — | Microvasive Tandem XL Cannula Named without a submission number |
What descends from it? (8)
2 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?
- Of its descendants, K010610 (Boston Scientific Corp, 2001) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The TandemRX is indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.
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/K970054 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970054: Tandemrx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970054
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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