510(k) · Cleared
ClearedAckrad Fluid Connecting Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ackrad Laboratories · LHI Set, I.V. Fluid Transfer
Cleared on Apr 26, 1982 after a 21-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
- Apr 26, 1982
- Review
- 21 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK820937 Ackrad Fluid Connecting SetAckrad Laboratories · 1982
- Descendant · cites it directly · 2 of its ownK980738 Psi-Tec Syringe Infusion Pump and Accessories for General Fluid…Byron Medical · 1998
- Descendant · 2 generations on · 1 of its ownK153599 Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016
- Descendant · 3 generations on · 0 of its ownK230083 SafiraMedovate Limited · 2023
- Descendant · cites it directly · 0 of its ownK974295 Byron Medical Aspiration and Infiltration/Irrigation TubingByron Medical · 1998
Most influential descendants
Showing 4 of 4 · See all- K980738Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationByron Medical · 1998 · cites it directly2descendants
- K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016 · 2 generations on1descendant
- K230083SafiraMedovate Limited · 2023 · 3 generations on0descendants
- K974295Byron Medical Aspiration and Infiltration/Irrigation TubingByron Medical · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820937 | Ackrad Fluid Connecting Set | Ackrad Laboratories | 1982 | — |
| +1 | K980738 | Psi-Tec Syringe Infusion Pump and Accessories for General Fluid… | Byron Medical | 1998 | — |
| +2 | K153599 | Concert Medical Hands-Free Syringe (HFS) | Concert Medical, LLC | 2016 | — |
| +3 | K230083 | Safira | Medovate Limited | 2023 | — |
| +1 | K974295 | Byron Medical Aspiration and Infiltration/Irrigation Tubing | Byron Medical | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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 LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 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, K980738 (Byron Medical, 1998) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K820937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K820937: Ackrad Fluid Connecting Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820937
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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