510(k) · Cleared
ClearedAtrion Medical QL Fluid Dispensing Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrion Medical Products, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Apr 25, 2002 as substantially equivalent to K972964 (Atrion Medical Products, Inc., 1997) after an 84-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- Apr 25, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- DXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K953522 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- 2 generations backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- 1 generation backK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
- This deviceK020333 Atrion Medical QL Fluid Dispensing SyringeAtrion Medical Products, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK102192 Indiscal Digital ManometerBaylis Medical Co., Inc. · 2011
- Descendant · cites it directly · 0 of its ownK050753 Stryker DiscmonitorStryker Instruments · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| −2 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| −1 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| 0 (this device) | K020333 | Atrion Medical QL Fluid Dispensing Syringe | Atrion Medical Products, Inc. | 2002 | — |
| +1 | K102192 | Indiscal Digital Manometer | Baylis Medical Co., Inc. | 2011 | — |
| +1 | K050753 | Stryker Discmonitor | Stryker Instruments | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 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 DXT? 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 DXT device
- #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 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 |
|---|---|---|---|
| * | K972964 | Atrion Medical Balloon Catheter Inflation DeviceSummary page 1…29 Email: [email protected] Predicate: Atrion Medical Products Balloon Catheter Inflation Device, cleared for market on October 10, 1997 under 510(k) submission K972964. The new device will have the same intended use as the Monarch (IN 2125)/Intellisystem (IN 1125), which was cleared for market on… | 1997 |
| † | K973230 | Monarch (in 2125)/Intellisystem (in 1125) | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102192 (Baylis Medical Co., Inc., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K972964.
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXT
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXT
10in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXT
97in 2025
MAUDE reports naming product code DXT, 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 | 3 | 182 | 4 | 107 |
| 2008 | 2 | — | 3 | 168 |
| 2009 | 6 | 137 | 7 | 188 |
| 2010 | 1 | — | 3 | 124 |
| 2011 | 4 | 69 | 3 | 133 |
| 2012 | 0 | — | 7 | 135 |
| 2013 | 2 | — | 0 | 141 |
| 2014 | 6 | 144 | 0 | 97 |
| 2015 | 7 | 153 | 1 | 135 |
| 2016 | 8 | 172 | 0 | 152 |
| 2017 | 7 | 183 | 0 | 128 |
| 2018 | 9 | 93 | 2 | 129 |
| 2019 | 4 | 96 | 0 | 121 |
| 2020 | 3 | 154 | 1 | 93 |
| 2021 | 1 | — | 1 | 132 |
| 2022 | 0 | — | 0 | 111 |
| 2023 | 1 | — | 2 | 117 |
| 2024 | 4 | 138 | 10 | 118 |
| 2025 | 1 | — | 0 | 97 |
| 2026 | 7 | 264 | 6 | — |
What is it indicated for?
The syringe is intended for single use by healthcare professionals to dispense fluids to the body and monitor the pressure of those fluids.
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/K020333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020333: Atrion Medical QL Fluid Dispensing Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020333
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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