510(k) · Cleared
ClearedCystoject Syringe Lever
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urogen Pharma, Ltd. · QBL Piston Syringe Lever
Cleared on Dec 9, 2020 as substantially equivalent to K190987 (Urogen Pharma, Ltd., 2019) after a 27-day review. Its family tree reaches back 4 generations to 1982.
- Decided
- Dec 9, 2020
- Review
- 27 days
- Class
- Class II
- Product code
- QBL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K820164 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK820164 Empty Sterile CarpujectSterling Drug, Inc. · 1982
- 3 generations backK063180 Isecure Syringe Cartridge HolderHospira, Inc. · 2006
- 2 generations backK180345 Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2018
- 1 generation backK190987 Uroject12 Syringe LeverUrogen Pharma, Ltd. · 2019
- This deviceK203321 Cystoject Syringe LeverUrogen Pharma, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820164 | Empty Sterile Carpuject | Sterling Drug, Inc. | 1982 | — |
| −3 | K063180 | Isecure Syringe Cartridge Holder | Hospira, Inc. | 2006 | — |
| −2 | K180345 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | 2018 | — |
| −1 | K190987 | Uroject12 Syringe Lever | Urogen Pharma, Ltd. | 2019 | — |
| 0 (this device) | K203321 | Cystoject Syringe Lever | Urogen Pharma, Ltd. | 2020 | — |
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 QBL? 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? (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 |
|---|---|---|---|
| * | K190987 | Uroject12 Syringe LeverSummary page 5…e-mail: [email protected] III. PREDICATE DEVICES Predicate device Uroject12 Syringe Lever, by UroGen Pharma, Ltd., Product code QBL, cleared under: K190987. This predicate has not been subject to a design-related recall. 510(k) Summary This 510(k) summary of safety and effecti… | 2019 |
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 38 years and passes through 3 companies; a new generation was cleared every 11.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QBL devicesQBL Piston Syringe Lever: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QBL
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QBL
Too few QBL 510(k)s in any year since 2007 to give a median.
Recalls per year · QBL
No recall names QBL since 2007.
Adverse event reports per year · QBL
2in 2023
MAUDE reports naming product code QBL, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cystoject Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.
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/K203321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203321: Cystoject Syringe Lever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203321
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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