510(k) · Cleared
Recalled · Class II · 2025Induction and Sampling Manifold (or Stopcock)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elcam Medical Acal · FMG Stopcock, I.V. Set
Cleared on Sep 12, 2003 as substantially equivalent to K000152 (The Kipp Group, 2000) and 1 other predicate after a 39-day review. Its family tree reaches back 2 generations to 1986. 18 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 12, 2003
- Review
- 39 days
- Class
- Class II
- Product code
- FMG
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K862691 (1986). 3 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK862691 StopcockRam Development · 1986
- 1 generation backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- This deviceK032393 Induction and Sampling Manifold (or Stopcock)Elcam Medical Acal · 2003
- Descendant · cites it directly · 12 of its ownK033793 Cleaner II Rotational Thrombectomy SystemRex Medical · 2003
- Descendant · 2 generations on · 11 of its ownK040252 Cleaner Rotational Thrombectomy System KitRex Medical · 2004
- Descendant · 3 generations on · 10 of its ownK060904 Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006
- Descendant · 4 generations on · 9 of its ownK091029 Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X…Rex Medical · 2010
- Descendant · 4 generations on · 8 of its ownK120346 Cleaner Rotational Thrombectomy SystemRex Medical · 2012
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K033793Cleaner II Rotational Thrombectomy SystemRex Medical · 2003 · cites it directly12descendants
- K040252Cleaner Rotational Thrombectomy System KitRex Medical · 2004 · 2 generations on11descendants
- K060904Cleaner Rotational Thrombectomy SystemRex Medical, L.P. · 2006 · 3 generations on10descendants
- K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical · 2010 · 4 generations on9descendants
- K120346Cleaner Rotational Thrombectomy SystemRex Medical · 2012 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862691 | Stopcock | Ram Development | 1986 | — |
| −1 | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | 14 |
| 0 (this device) | K032393 | Induction and Sampling Manifold (or Stopcock) | Elcam Medical Acal | 2003 | — |
| +1 | K033793 | Cleaner II Rotational Thrombectomy System | Rex Medical | 2003 | — |
| +2 | K040252 | Cleaner Rotational Thrombectomy System Kit | Rex Medical | 2004 | — |
| +3 | K060904 | Cleaner Rotational Thrombectomy System | Rex Medical, L.P. | 2006 | — |
| +4 | K091029 | Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM) | Rex Medical | 2010 | — |
| +4 | K120346 | Cleaner Rotational Thrombectomy System | Rex Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 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? (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.
What descends from it? (18)
See all 182 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K033793 (Rex Medical, 2003) has gone furthest, with 12 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 Induction & Sampling Manifold [or Stopcock] is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V. fluids delivery to the patient’s vascular system. The product is intended for delivering I.V. drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032393: Induction and Sampling Manifold (or Stopcock).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032393
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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