510(k) · Cleared
Recalled · Class II · 2025Safeport Manifold (TM) (or Stopcock)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elcam Medical Acal · FPA Set, Administration, Intravascular
Cleared on Jun 9, 2011 as substantially equivalent to K032393 (Elcam Medical Acal, 2003) after a 58-day review. Its family tree reaches back 3 generations to 1986. 4 later devices descend from it. It has been recalled 12 times.
- Decided
- Jun 9, 2011
- Review
- 58 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 12
- Predicates
- 1
Its longest line of descent runs back 3 generations to K862691 (1986). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK862691 StopcockRam Development · 1986
- 2 generations backK022895 Elcam Stopcocks and ManifoldsMedical Device Consultants, Inc. · 2002 · Recalled
- 1 generation backK032393 Induction and Sampling Manifold (or Stopcock)Elcam Medical Acal · 2003 · Recalled
- This deviceK111016 Safeport Manifold (TM) (or Stopcock)Elcam Medical Acal · 2011
- Descendant · cites it directly · 1 of its ownK123084 Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP…Elcam Medical Acal · 2013
- Descendant · 2 generations on · 0 of its ownK242255 Qitexio® 4-Way Stopcock (QIT014)Medex · 2025
- Descendant · cites it directly · 0 of its ownK210516 Clicky CrossYomura Technologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK172266 Dynarex Three-Way StopcockDynarex Corporation · 2018
Most influential descendants
Showing 4 of 4 · See all- K123084Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…Elcam Medical Acal · 2013 · cites it directly1descendant
- K242255Qitexio® 4-Way Stopcock (QIT014)Medex · 2025 · 2 generations on0descendants
- K210516Clicky CrossYomura Technologies, Inc. · 2022 · cites it directly0descendants
- K172266Dynarex Three-Way StopcockDynarex Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862691 | Stopcock | Ram Development | 1986 | — |
| −2 | K022895 | Elcam Stopcocks and Manifolds | Medical Device Consultants, Inc. | 2002 | 14 |
| −1 | K032393 | Induction and Sampling Manifold (or Stopcock) | Elcam Medical Acal | 2003 | 2 |
| 0 (this device) | K111016 | Safeport Manifold (TM) (or Stopcock) | Elcam Medical Acal | 2011 | — |
| +1 | K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP… | Elcam Medical Acal | 2013 | — |
| +2 | K242255 | Qitexio® 4-Way Stopcock (QIT014) | Medex | 2025 | — |
| +1 | K210516 | Clicky Cross | Yomura Technologies, Inc. | 2022 | — |
| +1 | K172266 | Dynarex Three-Way Stopcock | Dynarex Corporation | 2018 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K032393 | Induction and Sampling Manifold (or Stopcock)Summary page 1…E-mail: Llovd.fishmancaelcam-medical corn Predicate Device: Elcam's Induction & Sampling Manifold (or Stopcock) cleared under 510(k) # K032393. Device Name Common/ Usual Name: SafePort Manifold"' (or Stopcock) Proprietary/ Trade Name: SafePort Manif old' (or Stopcock)… | 2003 |
What descends from it? (4)
3 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-0629-2026 | 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-0631-2026 | 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-0637-2026 | 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-0664-2026 | 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-0665-2026 | 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-0693-2026 | 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-0695-2026 | 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-0699-2026 | 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-0635-2026 | 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-0656-2026 | 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-0696-2026 | 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. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K123084 (Elcam Medical Acal, 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K032393.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
Safeport Manifold is indicated to serve as a flow control and a conduit device for ILV fluids delivery to the patient's vascular system. The product is intended for delivering 1.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/K111016 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111016: Safeport Manifold (TM) (or Stopcock).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111016
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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