510(k) · Cleared
ClearedChemo-Spike II Reconstitution Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Dose, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Jan 8, 1998 as substantially equivalent to K941020 (Gelman Sciences, Inc., 1994) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1994. 2 of the 16 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Jan 8, 1998
- Review
- 45 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941020 (1994). 2 ancestors in all. 13 later devices descend from it, 1 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK941020 Drug Reconstitution Filter DeviceGelman Sciences, Inc. · 1994
- This deviceK974431 Chemo-Spike II Reconstitution DeviceMedi-Dose, Inc. · 1998
- Descendant · cites it directly · 12 of its ownK081361 Chemoclave Cytotoxic Medication Preparation and Delivery System…Icu Medical, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK131549 Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 9 of its ownK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- Descendant · 4 generations on · 3 of its ownK192866 Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · Recalled
- Descendant · 4 generations on · 1 of its ownK201422 Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · cites it directly12descendants
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 2 generations on10descendants
- K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015 · 3 generations on9descendants
- K192866Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · 4 generations on3descendants
- K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941020 | Drug Reconstitution Filter Device | Gelman Sciences, Inc. | 1994 | — |
| 0 (this device) | K974431 | Chemo-Spike II Reconstitution Device | Medi-Dose, Inc. | 1998 | — |
| +1 | K081361 | Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX | Icu Medical, Inc. | 2008 | Class I |
| +2 | K131549 | Chemolock, Chemolock Port | Icu Medical, Inc. | 2013 | Class I |
| +3 | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
| +4 | K192866 | Chemfort CSTD | Simplivia Healthcare, Ltd. | 2020 | 1 |
| +4 | K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2013 | 1 | 1 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
2 devices in this family have 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? (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 |
|---|---|---|---|
| * | K941020 | Drug Reconstitution Filter DeviceSummary page 1…VI Plastics testing has been conducted on the device and has been found to be biosafe. The Chemo-Spike II Reconstitution Device is the predicate device granted 510(k) #K941020, manufactured by Gelman Sciences, Inc. Gelman Sciences, Inc. is the actual subcontractor of this product. The Chemo-Spike II Reco… | 1994 |
| * | K946190 | Drug Dispensing SpikeSummary page 2…easures 1.0 cm”. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe. Please note that this product has been granted 510(k) #K946190 to Gelman Sciences, Inc. of Ann Arbor, MI. Gelman Sciences is the actual subcontractor of this product. The only change between t… | 1995 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081361 | Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX Class I | 2008 | 12 |
Has anything in its family been recalled? (2 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.
- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K081361 (Icu Medical, Inc., 2008) has gone furthest, with 12 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 | — |
What is it indicated for?
The Chemo-Spike II Reconstitution Device is indicated for use in the preparation and dispensing of lyophilized chemotherapy drugs in multiple dose vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel properly trained in aseptic procedures. The Chemo-Spike II Reconstitution Device is indicated for use prior to patient administration…
Read the full statement (143 words)
The Chemo-Spike II Reconstitution Device is indicated for use in the preparation and dispensing of lyophilized chemotherapy drugs in multiple dose vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel properly trained in aseptic procedures. The Chemo-Spike II Reconstitution Device is indicated for use prior to patient administration or physician use.
The Dispensing-Spike II Device is indicated for use in the preparation and dispensing of IV medication from multiple dose IV vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel skilled and trained in maintaining aseptic technique. The Dispensing-Spike II is indicated for use prior to patient administration or physician use.
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/K974431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974431: Chemo-Spike II Reconstitution Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974431
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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