510(k) · Cleared
ClearedAltaviz Intravitreal Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altaviz, LLC · QLY Ophthalmic Syringe
Cleared on May 9, 2025 as substantially equivalent to K941562 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) after a 198-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 9, 2025
- Review
- 198 days
- Class
- Class II
- Product code
- QLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941562 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941562 1ML Luer-Lok SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- This deviceK243322 Altaviz Intravitreal SyringeAltaviz, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941562 | 1ML Luer-Lok Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| 0 (this device) | K243322 | Altaviz Intravitreal Syringe | Altaviz, LLC | 2025 | — |
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 |
|---|---|---|---|
| * | K941562 | 1ML Luer-Lok SyringeSummary page 5…Syringe Product Code: QLY (Ophthalmic Syringe), FMF (Syringe, Piston); 21 CFR 880.5860 Classification: II Predicate Device 510(k) Number K941562 Device 1mL Luer-Lok Syringe 1 Device Descrip… | 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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K941562.
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 Altaviz Intravitreal Syringe is intended for use by heath care professionals for general purpose fluid aspiration/injection. It is indicated for general and intravitreal use in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243322 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243322: Altaviz Intravitreal Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243322
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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