510(k) · Cleared
ClearedQL Locking Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrion Medical Products, Inc. · MAV Syringe, Balloon Inflation
Cleared on Jul 12, 2006 as substantially equivalent to K032840 (Atrion Medical Products, Inc., 2004) and 1 other predicate after a 124-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jul 12, 2006
- Review
- 124 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953522 (1996). 6 ancestors in all, the oldest K955869 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- 3 generations backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- 2 generations backK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
- 1 generation backK032840 Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004
- This deviceK060643 QL Locking SyringeAtrion Medical Products, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| −3 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| −2 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| −1 | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| 0 (this device) | K060643 | QL Locking Syringe | Atrion Medical Products, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2004 | 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 MAV? 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 MAV device
- #1 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K032840 | Atrion Medical QL Inflation DeviceSummary page 1…Fax: (256) 586-8529 Email: [email protected] Predicates: Atrion Medical Products, Inc, QL® Inflation Device, K032840. Merit Medical Systems, Inc. Viceroy TM Inflation device, K040138 Device Description: The Atrion Medical QL® L… | 2004 |
| * | K040138 | Viceroy Inflation DeviceSummary page 1…[email protected] Predicates: Atrion Medical Products, Inc, QL® Inflation Device, K032840. Merit Medical Systems, Inc. Viceroy TM Inflation device, K040138 Device Description: The Atrion Medical QL® Locking Syringe Device consists of a plastic syringe with a screw-t… | 2004 |
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 10 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 4 other devices also cite its predicate K032840.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MAV
69in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAV
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAV
66in 2025
MAUDE reports naming product code MAV, 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 | 37 |
| 2008 | 1 | — | 0 | 50 |
| 2009 | 0 | — | 0 | 99 |
| 2010 | 0 | — | 3 | 88 |
| 2011 | 1 | — | 0 | 94 |
| 2012 | 4 | 85 | 0 | 251 |
| 2013 | 1 | — | 0 | 245 |
| 2014 | 2 | — | 2 | 92 |
| 2015 | 3 | 116 | 0 | 121 |
| 2016 | 3 | 69 | 1 | 124 |
| 2017 | 0 | — | 0 | 246 |
| 2018 | 0 | — | 1 | 300 |
| 2019 | 0 | — | 0 | 199 |
| 2020 | 0 | — | 0 | 101 |
| 2021 | 0 | — | 0 | 186 |
| 2022 | 1 | — | 5 | 437 |
| 2023 | 0 | — | 0 | 220 |
| 2024 | 0 | — | 4 | 420 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060643: QL Locking Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060643
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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