510(k) · Cleared
ClearedBackstop and Backstop Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pluromed, Inc. · ONJ Dissolvable Gel For Preventing Ureteral Stone Migration
Cleared on Jun 2, 2009 as substantially equivalent to K863081 (Cook Urological, Inc., 1986) and 3 other predicates after a 103-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Jun 2, 2009
- Review
- 103 days
- Class
- Class II
- Product code
- ONJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K871777 (1987). 8 ancestors in all, the oldest K863081 (1986). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871777 | Van-Tec Reusable Helical Stone Basket | Van-Tec, Inc. | 1987 | — |
| −1 | K970121 | Stone Dislodger, Basket | Boston Scientific Corp | 1997 | — |
| 0 (this device) | K090430 | Backstop and Backstop Injector | Pluromed, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 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 ONJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K863081 | 4-Wire (Carson) Stone ExtractorSummary page 1…ribed in this Premnarket Notification under section 514 of the FD&C Act. Predicates: 1. Cook Urological N-Tra pT M (K863081) 2. Boston Scientific Stone ConeT M (K970121) 3. Boston Scie… | 1986 |
| * | K970121 | Stone Dislodger, BasketSummary page 1…FD&C Act. Predicates: 1. Cook Urological N-Tra pT M (K863081) 2. Boston Scientific Stone ConeT M (K970121) 3. Boston Scientific Temporary Indwelling Ureteral Catheter /… | 1997 |
| * | K013784 | Ureteral StentSummary page 1…oneT M (K970121) 3. Boston Scientific Temporary Indwelling Ureteral Catheter / Ureteral Stent (K013784) 4. Boston Scientific Temnp-Tip Drainage Catheter (K924608) Description of Device:… | 2002 |
| * | K924608 | Hydrogel Coated Percuflex (R) Drainage CathetersSummary page 1…Ureteral Catheter / Ureteral Stent (K013784) 4. Boston Scientific Temnp-Tip Drainage Catheter (K924608) Description of Device: BackSto pTM is a self-forming polymeric plug with reverse ther… | 1994 |
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 22 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K863081.
How does its category compare?
All ONJ devicesONJ Dissolvable Gel For Preventing Ureteral Stone Migration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ONJ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · ONJ
Too few ONJ 510(k)s in any year since 2007 to give a median.
Recalls per year · ONJ
No recall names ONJ since 2007.
Adverse event reports per year · ONJ
1in 2015
MAUDE reports naming product code ONJ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
BackStop is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090430 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090430: Backstop and Backstop Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090430
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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