510(k) · Cleared
Recalled · Class II · 2022Guarded Luer Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medical Industries, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Jun 7, 2018 as substantially equivalent to K900585 (Baxa Corp., Sub. of Cook Group, Inc., 1990) after a 199-day review. Its family tree reaches back 1 generation to 1990. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Jun 7, 2018
- Review
- 199 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900585 (1990). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK900585 Tubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 1990 · Recalled (Class I)
- This deviceK173577 Guarded Luer ConnectorInternational Medical Industries, Inc. · 2018
Class I recalls in this family
- K900585 Tubing Sets for Baxa Exacta-Med Pharmacy Pumpdirect predicate · 1990
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900585 | Tubing Sets for Baxa Exacta-Med Pharmacy Pump | Baxa Corp., Sub. of Cook Group, Inc. | 1990 | Class I |
| 0 (this device) | K173577 | Guarded Luer Connector | International Medical Industries, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K900585 | Tubing Sets for Baxa Exacta-Med Pharmacy PumpSummary page 4…evice: TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP (K900585) Device Description The Guarded Luer Connector (GLC) is a polypropylene, sterile device, single use product intended to provide… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2022 | Class II | Z-0925-2023 | Process control | Blister package had an unsealed edge compromising sterility. |
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.
- K900585Tubing Sets for Baxa Exacta-Med Pharmacy PumpBaxa Corp., Sub. of Cook Group, Inc. · 1990 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
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. 2018, 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 Guarded Luer Connector is a fluid transfer device used in the pharmacy to provide the fluid path for transferring large source container ingredients into a smaller container.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173577 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173577: Guarded Luer Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173577
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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