510(k) · Cleared
ClearedEquashield System Protective Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Equashield Medical, Ltd. · LHI Set, I.V. Fluid Transfer
Cleared on Nov 19, 2010 as substantially equivalent to K083152 (Plastmed, Ltd., 2009) and 1 other predicate after a 130-day review. Its family tree reaches back 6 generations to 1988. 7 later devices descend from it.
- Decided
- Nov 19, 2010
- Review
- 130 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K883614 (1988). 13 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 5 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 4 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 3 generations backK051669 Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant · 2005 · Recalled
- 2 generations backK083152 Equashield SystemPlastmed, Ltd. · 2009
- 1 generation backK091389 Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009
- This deviceK101940 Equashield System Protective PlusEquashield Medical, Ltd. · 2010
- Descendant · cites it directly · 6 of its ownK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
- Descendant · 2 generations on · 5 of its ownK170706 Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK201460 Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022
- Descendant · 4 generations on · 2 of its ownK241988 ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd. · 2024
- Descendant · 5 generations on · 0 of its ownK251340 ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014 · cites it directly6descendants
- K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017 · 2 generations on5descendants
- K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022 · 3 generations on3descendants
- K241988ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd. · 2024 · 4 generations on2descendants
- K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −5 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −4 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −3 | K051669 | Tevadaptor Closed Drug Reconstitution and Transfer System | Migada Plant | 2005 | 1 |
| −2 | K083152 | Equashield System | Plastmed, Ltd. | 2009 | — |
| −1 | K091389 | Equalshield Luer Lock Connector Pair | Plastmed, Ltd. | 2009 | — |
| 0 (this device) | K101940 | Equashield System Protective Plus | Equashield Medical, Ltd. | 2010 | — |
| +1 | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
| +2 | K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2017 | — |
| +3 | K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022 | — |
| +4 | K241988 | ProSeal™ Closed System Bag Access | Epic Medical Pte., Ltd. | 2024 | — |
| +5 | K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K083152 | Equashield SystemSummary page 1…the original EQUASHIELD~m System for the preparation and administration of parenteral drugs, cleared under 51 0(k) number K083 152 and to the EQUASHIELD~m Luer Lock Connector Pair cleared under 5 10(k) number K09… | 2009 |
| * | K091389 | Equalshield Luer Lock Connector PairSummary page 1…rugs, cleared under 51 0(k) number K083 152 and to the EQUASHIELD~m Luer Lock Connector Pair cleared under 5 10(k) number K09 1389. EQUASHIELD Medical Ltd. I Protective Plug Special 510k, Appendix D Page 2 of 5… | 2009 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132899 | Equashield Closed System Drug Transfer Device (CSTD) | 2014 | 6 |
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 22 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K132899 (Equashield Medical, Ltd., 2014) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K083152.
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. 2010, this device’s year, is highlighted.
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 EQUASHIELD™ System reconstitution and transfer system is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs for intravenous infusion or injection.
The EQUASHIELD™ System has an additional Protective Plug accessory which functions as a feature that mechanically prohibits the entrance of any objects into the EQUASHIELD™ System by physically blocking and protecting the system's connector ports.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101940 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101940: Equashield System Protective Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101940
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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