510(k) · Cleared
Recalled · Class II · 2025Elcam Stopcocks and Manifolds
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Consultants, Inc. · FMG Stopcock, I.V. Set
Cleared on Oct 18, 2002 as substantially equivalent to K862691 (Ram Development, 1986) after a 45-day review. Its family tree reaches back 1 generation to 1986. 29 later devices descend from it. It has been recalled 14 times.
- Decided
- Oct 18, 2002
- Review
- 45 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 14
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862691 (1986). 29 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK862691 StopcockRam Development · 1986
- This deviceK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002
- Descendant · cites it directly · 18 of its ownK032393 Induction and Sampling Manifold (or Stopcock)Elcam Medical Acal · 2003 · Recalled
- Descendant · 2 generations on · 12 of its ownK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- Descendant · 3 generations on · 11 of its ownK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- Descendant · 4 generations on · 10 of its ownK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
- Descendant · 5 generations on · 9 of its ownK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K032393Induction and Sampling Manifold (or Stopcock)Elcam Medical Acal · 2003 · cites it directly18descendants
- K033793Cleaner II Rotational Thrombectomy SystemRex Medical · 2003 · 2 generations on12descendants
- K040252Cleaner Rotational Thrombectomy System KitRex Medical · 2004 · 3 generations on11descendants
- K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006 · 4 generations on10descendants
- K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical · 2010 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862691 | Stopcock | Ram Development | 1986 | — |
| 0 (this device) | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | — |
| +1 | K032393 | Induction and Sampling Manifold (or Stopcock) | Elcam Medical Acal | 2003 | 2 |
| +2 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| +3 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| +4 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
| +5 | K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) | Rex Medical | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 FMG? 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 FMG device
- #1 K242255 Qitexio® 4-Way Stopcock (QIT014)score 10.5 · 5 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 |
|---|---|---|---|
| * | K862691 | StopcockSummary page 1…spital 3. PREDICATE DEVICES Elcam Stopcocks and Manifolds are substantially equivalent to ElcamdRAM Development stopcocks, 5 1O(k) No. K86269 1. 4. DEVICE DESCRIPTION Elcam Stopcocks and Manifolds are composed of a body with two or three ports and a han… | 1986 |
What descends from it? (29)
See all 295 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032393 | Induction and Sampling Manifold (or Stopcock) | 2003 | 18 |
| K060231 | Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock | 2006 | 4 |
| K053405 | Bacstop | 2006 | 2 |
| K141254 | Elcam Stopcocks and Manifolds | 2014 | 1 |
| K190539 | TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal… | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2025 | Class II | Z-0642-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0644-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0641-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0643-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Oct 29, 2025 | Class II | Z-0717-2026 | Process control | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| Aug 8, 2024 | Class II | Z-3144-2024 | Process change control | Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process. |
| Nov 20, 2019 | Class II | Z-0936-2020 | Nonconforming Material/Component | Potential for leakage at the joint between the blood filters and tubing |
| Nov 20, 2019 | Class II | Z-0938-2020 | Nonconforming Material/Component | Potential for leakage at the joint between the blood filters and tubing |
| Dec 15, 2005 | Not classified | Z-0654-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Dec 15, 2005 | Not classified | Z-0655-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Dec 15, 2005 | Not classified | Z-0656-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Dec 15, 2005 | Not classified | Z-0646-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Dec 15, 2005 | Not classified | Z-0653-06 | Other | The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication. |
| Apr 21, 2005 | Not classified | Z-0943-05 | Other | There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K032393 (Elcam Medical Acal, 2003) has gone furthest, with 18 descendants of its own.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMG
Too few FMG 510(k)s in any year since 2007 to give a median.
Recalls per year · FMG
33in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMG
868in 2025
MAUDE reports naming product code FMG, 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 | 2 | — | 5 | 26 |
| 2008 | 2 | — | 4 | 48 |
| 2009 | 2 | — | 0 | 27 |
| 2010 | 0 | — | 2 | 131 |
| 2011 | 0 | — | 8 | 95 |
| 2012 | 0 | — | 0 | 93 |
| 2013 | 2 | — | 0 | 117 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 96 |
| 2016 | 0 | — | 1 | 148 |
| 2017 | 0 | — | 2 | 114 |
| 2018 | 1 | — | 3 | 164 |
| 2019 | 2 | — | 0 | 400 |
| 2020 | 0 | — | 5 | 284 |
| 2021 | 0 | — | 0 | 245 |
| 2022 | 2 | — | 0 | 280 |
| 2023 | 2 | — | 0 | 689 |
| 2024 | 0 | — | 0 | 935 |
| 2025 | 1 | — | 33 (1) | 868 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022895 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022895: Elcam Stopcocks and Manifolds.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022895
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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