510(k) · Cleared
ClearedEquashield System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plastmed, Ltd. · LHI Set, I.V. Fluid Transfer
Cleared on Feb 2, 2009 as substantially equivalent to K972527 (Quality System Consulting, 1997) and 2 other predicates after a 101-day review. Its family tree reaches back 4 generations to 1988. 9 later devices descend from it.
- Decided
- Feb 2, 2009
- Review
- 101 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K883614 (1988). 11 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 3 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 2 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 1 generation backK051669 Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant · 2005 · Recalled
- This deviceK083152 Equashield SystemPlastmed, Ltd. · 2009
- Descendant · cites it directly · 8 of its ownK091389 Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009
- Descendant · cites it directly · 7 of its ownK101940 Equashield System Protective PlusEquashield Medical, Ltd. · 2010
- Descendant · 2 generations on · 6 of its ownK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
- Descendant · 3 generations on · 5 of its ownK170706 Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017
- Descendant · 4 generations on · 3 of its ownK201460 Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K091389Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009 · cites it directly8descendants
- K101940Equashield System Protective PlusEquashield Medical, Ltd. · 2010 · cites it directly7descendants
- K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014 · 2 generations on6descendants
- K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017 · 3 generations on5descendants
- K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −3 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −2 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −1 | K051669 | Tevadaptor Closed Drug Reconstitution and Transfer System | Migada Plant | 2005 | 1 |
| 0 (this device) | K083152 | Equashield System | Plastmed, Ltd. | 2009 | — |
| +1 | K091389 | Equalshield Luer Lock Connector Pair | Plastmed, Ltd. | 2009 | — |
| +1 | K101940 | Equashield System Protective Plus | Equashield Medical, Ltd. | 2010 | — |
| +2 | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
| +3 | K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2017 | — |
| +4 | K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic AgentsSummary page 1…s claimed: 1. PhaSeal closed system for the preparation and administration of parenteral drugs; Carmel Pharma. AB K972527 2. TEVADAPTOR; Mfigada Plant K05 1669 3. Texiufm~ Syringe; Cardinal Health, A… | 1997 |
| * | K051669 | Tevadaptor Closed Drug Reconstitution and Transfer SystemSummary page 1…for the preparation and administration of parenteral drugs; Carmel Pharma. AB K972527 2. TEVADAPTOR; Mfigada Plant K05 1669 3. Texiufm~ Syringe; Cardinal Health, Aleris® Prodticts K071 108… | 2005 |
| * | K071108 | Texium SyringeSummary page 1…rmel Pharma. AB K972527 2. TEVADAPTOR; Mfigada Plant K05 1669 3. Texiufm~ Syringe; Cardinal Health, Aleris® Prodticts K071 108 2-2 Plastmed Ltd. IEQUASHIELD TM 510k Notification ===… | 2007 |
What descends from it? (9)
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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 7.5 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K091389 (Plastmed, Ltd., 2009) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K972527.
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. 2009, 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 TM Drug 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083152: Equashield System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083152
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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