510(k) · Cleared
ClearedStaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Staclear, Inc. · QLY Ophthalmic Syringe
Cleared on Nov 21, 2025 as substantially equivalent to K243936 (Staclear, Inc., 2025) after a 158-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Nov 21, 2025
- Review
- 158 days
- Class
- Class II
- Product code
- QLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K931367 (1993). 23 ancestors in all, the oldest K822083 (1982). No later device cites it as a predicate yet.
- Root · 7 generations backK931367 Vacutainer Brand Luer AdapterBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- 6 generations backK021475 BD Single Lumen Needle, Syringe and Blood Collection SetBd · 2002 · Recalled
- 5 generations backK070440 BD Hypoint NeedleBecton, Dickinson & CO · 2007
- 4 generations backK072739 Jierui Syringes and NeedlesShandong Weigao Group Medical Polymer Co., Ltd. · 2008
- 3 generations backK163161 Sterile Single-use Syringe with NeedleJiangxi Hongda Medical Equipment Group, Ltd. · 2017
- 2 generations backK200242 StaClear SyringeTribofilm Research, Inc. · 2020
- 1 generation backK243936 StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear…Staclear, Inc. · 2025
- This deviceK251849 StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear…Staclear, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931367 | Vacutainer Brand Luer Adapter | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| −6 | K021475 | BD Single Lumen Needle, Syringe and Blood Collection Set | Bd | 2002 | 3 |
| −5 | K070440 | BD Hypoint Needle | Becton, Dickinson & CO | 2007 | — |
| −4 | K072739 | Jierui Syringes and Needles | Shandong Weigao Group Medical Polymer Co., Ltd. | 2008 | — |
| −3 | K163161 | Sterile Single-use Syringe with Needle | Jiangxi Hongda Medical Equipment Group, Ltd. | 2017 | — |
| −2 | K200242 | StaClear Syringe | Tribofilm Research, Inc. | 2020 | — |
| −1 | K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe… | Staclear, Inc. | 2025 | — |
| 0 (this device) | K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe… | Staclear, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 QLY? 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 QLY device
- #1 K243936 StaClear Syringe (SC250AN); StaClear Syringe…score 13.6 · 6 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 |
|---|---|---|---|
| * | K243936 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)Summary page 5…21 CFR 880.5860 Regulatory Class: II Product Code: QLY Additional Product Code: FMF, FMI III. Predicate Device K243936 StaClear Syringe (SC250AN, SC250LS, SC250LL) The predicate device has not been subject to a design-related recall. IV. Device De… | 2025 |
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 32 years and passes through 7 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 23 ancestors have a recall of any class.
How does its category compare?
All QLY devicesQLY Ophthalmic Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QLY
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QLY
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QLY
No recall names QLY since 2007.
Adverse event reports per year · QLY
1in 2022
MAUDE reports naming product code QLY, 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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 4 | 176 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251849: StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251849
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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