510(k) · Cleared
ClearedHigh Pressure Contrast Injection Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Namic · DQO Catheter, Intravascular, Diagnostic
Cleared on Aug 24, 1982 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Aug 24, 1982
- Review
- 39 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK822100 High Pressure Contrast Injection LineNamic · 1982
- Descendant · cites it directly · 3 of its ownK023591 Ultra High Pressure Injector LinesDeroyal Industries, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK071196 Disposable High Pressure Injection Lines with and Without Rotating…Coeur, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK140356 Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK131770 Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2014
Most influential descendants
Showing 4 of 4 · See all- K023591Ultra High Pressure Injector LinesDeroyal Industries, Inc. · 2003 · cites it directly3descendants
- K071196Disposable High Pressure Injection Lines with and Without Rotating AdaptersCoeur, Inc. · 2007 · cites it directly2descendants
- K140356Summed High Pressure LineSunny Medical Device (Shenzhen) Co., Ltd. · 2015 · 2 generations on0descendants
- K131770Pressure Connecting TubeShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K822100 | High Pressure Contrast Injection Line | Namic | 1982 | — |
| +1 | K023591 | Ultra High Pressure Injector Lines | Deroyal Industries, Inc. | 2003 | — |
| +1 | K071196 | Disposable High Pressure Injection Lines with and Without Rotating Adapters | Coeur, Inc. | 2007 | — |
| +2 | K140356 | Summed High Pressure Line | Sunny Medical Device (Shenzhen) Co., Ltd. | 2015 | — |
| +2 | K131770 | Pressure Connecting Tube | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K023591 (Deroyal Industries, Inc., 2003) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
https://510kreport.com/device/K822100 · printed Nov 5, 2026
Cite this page
510(k) Report. “K822100: High Pressure Contrast Injection Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K822100
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026