510(k) · Cleared
ClearedRapid-Fill Tubeset, Model 90005
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxa Corp. · LHI Set, I.V. Fluid Transfer
Cleared on Aug 12, 2002 as substantially equivalent to K002705 (Baxa Corp., 2001) after a 13-day review. Its family tree reaches back 1 generation to 2001. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 12, 2002
- Review
- 13 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002705 (2001). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK002705 Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. · 2001 · Recalled (Class I)
- This deviceK022523 Rapid-Fill Tubeset, Model 90005Baxa Corp. · 2002
- Descendant · cites it directly · 0 of its ownK192770 S dispensing lineAea Srl · 2020
Class I recalls in this family
- K002705 Exacta-Mix 2400 Compounding System, Model…direct predicate · 2001
Most influential descendants
Showing 1 of 1 · See all- K192770S dispensing lineAea Srl · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002705 | Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400 | Baxa Corp. | 2001 | Class I |
| 0 (this device) | K022523 | Rapid-Fill Tubeset, Model 90005 | Baxa Corp. | 2002 | — |
| +1 | K192770 | S dispensing line | Aea Srl | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K002705 | Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Summary page 1…) Classification. Class I1 (performance standards) Predicate Device: Exacta-MixTM2400 Compounding System Administration Set 5 lO(k): K002705, Cleared March 28,2001 Baxa Corporation Englewood, CO Baxa 5 1O(k) Summ… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192770 | S dispensing line | 2020 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K002705Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. · 2001 · Direct predicate · ◆ on the line of descent in FIG. 16 Class I recalls
What does this lineage say?
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 | — |
What is it indicated for?
The Rapid-Fill Tubeset, manufactured by Baxa Corporation, is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller containers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022523 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022523: Rapid-Fill Tubeset, Model 90005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022523
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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