510(k) · Cleared
ClearedDisposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold
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 May 23, 2013 as substantially equivalent to K111016 (Elcam Medical Acal, 2011) and 1 other predicate after a 234-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it.
- Decided
- May 23, 2013
- Review
- 234 days
- Class
- Class II
- Product code
- FMG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K862691 (1986). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK862691 StopcockRam Development · 1986
- 3 generations backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- 2 generations backK032393 Induction and Sampling Manifold (or Stopcock)Elcam Medical Acal · 2003 · Recalled
- 1 generation backK111016 Safeport Manifold (TM) (or Stopcock)Elcam Medical Acal · 2011 · Recalled
- This deviceK123084 Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP…Elcam Medical Acal · 2013
- Descendant · cites it directly · 0 of its ownK242255 Qitexio® 4-Way Stopcock (QIT014)Medex · 2025
Most influential descendants
Showing 1 of 1 · See all- K242255Qitexio® 4-Way Stopcock (QIT014)Medex · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862691 | Stopcock | Ram Development | 1986 | — |
| −3 | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | 14 |
| −2 | K032393 | Induction and Sampling Manifold (or Stopcock) | Elcam Medical Acal | 2003 | 2 |
| −1 | K111016 | Safeport Manifold (TM) (or Stopcock) | Elcam Medical Acal | 2011 | 12 |
| 0 (this device) | K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP… | Elcam Medical Acal | 2013 | — |
| +1 | K242255 | Qitexio® 4-Way Stopcock (QIT014) | Medex | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111016 | Safeport Manifold (TM) (or Stopcock)Summary page 2…5DM Angiographic Manifold I KNo. K123084 K111016 K960431 2 Owner Elcamn Medical A.C.A.L. Elcam Medical A.C.A.L. Scientif… | 2011 |
| * | K960431 | Pressure Stopcock/ManifoldSummary page 2…Manifold I KNo. K123084 K111016 K960431 2 Owner Elcamn Medical A.C.A.L. Elcam Medical A.C.A.L. Scientific Device… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242255 | Qitexio® 4-Way Stopcock (QIT014) | 2025 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K242255 (Medex, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K111016.
How does its category compare?
All FMG devicesFMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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's High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended to serve as flow control and delivery devices for I.V fluids injection to the patient's vascular system. The devices are indicated for medium and high pressure injection of fluids such as, but not limited to, fluids used during angiography and angioplasty and during interventional radiology and cardiology procedures. Devices indication for medium and high pressure does not preclude its use for low pressure procedures. The High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123084: Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123084
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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