510(k) · Cleared
ClearedCML 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Aug 3, 2005 as substantially equivalent to K970855 (Icu Medical, Inc., 1997) after a 63-day review. Its family tree reaches back 1 generation to 1997. 16 later devices descend from it.
- Decided
- Aug 3, 2005
- Review
- 63 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970855 (1997). 16 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970855 Clave ConnectorIcu Medical, Inc. · 1997 · Recalled
- This deviceK051437 CML 1000Icu Medical, Inc. · 2005
- Descendant · cites it directly · 14 of its ownK053049 Alaris Safety Male LuerCardinal Health, Alaris Products · 2006 · Recalled
- Descendant · 2 generations on · 11 of its ownK071108 Texium SyringeCardinal Health, Alaris Products · 2007 · Recalled
- Descendant · 3 generations on · 9 of its ownK083152 Equashield SystemPlastmed, Ltd. · 2009
- Descendant · 4 generations on · 8 of its ownK091389 Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009
- Descendant · 4 generations on · 7 of its ownK101940 Equashield System Protective PlusEquashield Medical, Ltd. · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K053049Alaris Safety Male LuerCardinal Health, Alaris Products · 2006 · cites it directly14descendants
- K071108Texium SyringeCardinal Health, Alaris Products · 2007 · 2 generations on11descendants
- K083152Equashield SystemPlastmed, Ltd. · 2009 · 3 generations on9descendants
- K091389Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009 · 4 generations on8descendants
- K101940Equashield System Protective PlusEquashield Medical, Ltd. · 2010 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970855 | Clave Connector | Icu Medical, Inc. | 1997 | 52 |
| 0 (this device) | K051437 | CML 1000 | Icu Medical, Inc. | 2005 | — |
| +1 | K053049 | Alaris Safety Male Luer | Cardinal Health, Alaris Products | 2006 | 3 |
| +2 | K071108 | Texium Syringe | Cardinal Health, Alaris Products | 2007 | 1 |
| +3 | K083152 | Equashield System | Plastmed, Ltd. | 2009 | — |
| +4 | K091389 | Equalshield Luer Lock Connector Pair | Plastmed, Ltd. | 2009 | — |
| +4 | K101940 | Equashield System Protective Plus | Equashield Medical, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K970855 | Clave ConnectorSummary page 1…ration set (21 CFR 880.5440) §807.92(a)(3) Legally Marketed Substantially Equivalent Device: Clave Connector K970855 §807.92(a)(4) Description of Device: The Closed Male Luer is a normally closed two-… | 1997 |
What descends from it? (16)
See all 162 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?
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The CML, is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve device intended for use as an accessory to intravascular administration set. The CML provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter (which is inserted into the vein or artery).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051437: CML 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051437
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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