510(k) · Cleared
ClearedSwan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swan Valley Medical, Incorporated · KOB Catheter, Suprapubic (And Accessories)
Cleared on Oct 26, 2012 as substantially equivalent to K071459 (B.Braun Medical, Inc., 2007) after a 283-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Oct 26, 2012
- Review
- 283 days
- Class
- Class II
- Product code
- KOB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K944355 (1994). 8 ancestors in all, the oldest K941657 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 4 generations backK030683 Nipro Disposable SyringesNipro Medical Corp. · 2003
- 3 generations backK051574 Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
- 2 generations backK063280 Injekt SyringeB.Braun Medical, Inc. · 2006 · Recalled
- 1 generation backK071459 B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc. · 2007 · Recalled
- This deviceK120127 Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec)…Swan Valley Medical, Incorporated · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −4 | K030683 | Nipro Disposable Syringes | Nipro Medical Corp. | 2003 | — |
| −3 | K051574 | Nipro Disposable Syringe with or Without Needle | Nipro Medical Corp. | 2005 | — |
| −2 | K063280 | Injekt Syringe | B.Braun Medical, Inc. | 2006 | 2 |
| −1 | K071459 | B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes | B.Braun Medical, Inc. | 2007 | 2 |
| 0 (this device) | K120127 | Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical… | Swan Valley Medical, Incorporated | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2003 | 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 KOB? 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 KOB device
- #1 K240514 AMT Low-Profile Suprapubic Catheter & Drainage…score 8.9 · 3 generations · no Class I recall
What was it cleared against? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K010204 | FDA’s K010204 is Stryker Navigation System-Knee Module Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| Kept off the family tree | K012513 | FDA’s K012513 is Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| Kept off the family tree | K983367 | FDA’s K983367 is Qlicksmart Our reading of the summary gave K983367, FDA’s number for Qlicksmart (Handren Assoc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BladeFLASK and BladeSINGLE”. Kept off the family tree. Summary page 3…licksmart Q lcsatPySharps containment feature of BladeFLASK and QLicd. P) K983367 the T-SPeCm Catheter Punch BladeSINGLE Lt.Instrument.… | 1998 |
| * | K071459 | B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesSummary page 3…E Lt.Instrument. B. BaunMedcalT-SPeG~'m.Piston Syringe for Omnifix®D Syringe Bn. BanMdcl K07 1459 inflating/deflating catheter Inc. balloon Each component of th… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K071459.
How does its category compare?
All KOB devicesKOB Catheter, Suprapubic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KOB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KOB
Too few KOB 510(k)s in any year since 2007 to give a median.
Recalls per year · KOB
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOB
1in 2025
MAUDE reports naming product code KOB, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 18 |
| 2019 | 1 | — | 2 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeCe) Surgical System is intended for suprapubic bladder catheterization (cystostomy) and drainage. The catheter should not be allowed to remain indwelling for more than 29 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120127: Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120127
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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